预约演示

更新于：2025-09-09

Bevacizumab

贝伐珠单抗

更新于：2025-09-09

概要

基本信息

药物类型

单克隆抗体

别名

Bevacizumab(Genetical Recombination)、rhuMAb-VEGF、贝伐单抗

+ [17]

靶点

VEGF-A

作用方式

抑制剂

作用机制

VEGF-A抑制剂(血管内皮生长因子A抑制剂)、血管生成抑制剂

治疗领域

肿瘤神经系统疾病消化系统疾病+ [11]

在研适应症

不可切除的肝细胞癌肝细胞癌复发性胶质母细胞瘤+ [218]

非在研适应症

异戊酸血症急性嗜碱性粒细胞白血病急性嗜酸细胞白血病+ [281]

原研机构

Genentech, Inc.

在研机构

Hoffmann-La Roche, Inc.

National Cancer InstituteMerck Sharp & Dohme LLC

+ [26]

非在研机构

SanofiNSABP Foundation, Inc.

Mayo Clinic

+ [52]

权益机构

Roche Korea Co., Ltd.

Immune-Onc Therapeutics, Inc.

Roche Holding AG

+ [5]

最高研发阶段批准上市

首次获批日期

美国 (2004-02-26),

结肠癌直肠癌

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (美国)、加速批准 (美国)、孤儿药 (美国)

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结构/序列

Sequence Code 41632H

来源: *****

Sequence Code 41637L

来源: *****

关联

3,372

项与贝伐珠单抗相关的临床试验

NCT06696768

/ Recruiting临床1期IIT

Phase I Clinical Trial of CA-4948 (Emavusertib) in Combination With FOLFOX Plus Bevacizumab as Frontline Treatment in Patients With Metastatic Colorectal Cancer

This phase I trial studies the side effects and best dose of CA-4948 when given together with fluorouracil, leucovorin, oxaliplatin (FOLFOX) plus bevacizumab in treating patients with colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic). CA-4948 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The chemotherapy drugs used in FOLOX, fluorouracil and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Leucovorin is used with fluorouracil to treat colorectal cancer. Bevacizumab is in a class of medications called anti-angiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to the tumor. This may slow the growth and spread of the tumor. Giving CA-4948 with FOLFOX plus bevacizumab may be safe, tolerable and/or effective in treating patients with metastatic colorectal cancer.

开始日期2026-01-23

申办/合作机构

National Cancer Institute

NCT05375708

/ Suspended临床2期IIT

A Multicenter Phase II Randomized Trial to Evaluate Systemic Therapy Versus Systemic Therapy in Combination with Stereotactic Radiotherapy in Patients with Metastatic Colorectal Cancer

A small number of colorectal cancer patients with limited oligometastases may be candidates for local treatment of metastases (e.g., resection, ablation). However, it is unclear if patients with more extensive metastatic disease benefit from local therapies to control visible metastasis.
The purpose of this study is to assess the impact of stereotactic body radiation therapy (SBRT) in combination with systemic therapy compared to systemic therapy alone on safety and efficacy in patients with metastatic colorectal cancer (mCRC) and ≤10 metastases.

开始日期2025-12-01

申办/合作机构

University Medical Center of Utrecht

NCT06680258

/ Not yet recruiting临床3期

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of TPST-1120 in Combination With Atezolizumab Plus Bevacizumab Compared With Placebo Plus Atezolizumab Plus Bevacizumab in Patients With Unresectable or Metastatic Hepatocellular Carcinoma (HCC) Not Previously Treated With Systemic Therapy

The goal of this clinical trial is to determine if TPST-1120 in combination with atezolizumab and bevacizumab helps patients to live longer compared to atezolizumab and bevacizumab alone (the standard of care treatment) in adult patients with hepatocellular carcinoma that cannot be removed by surgery or has spread outside of the liver (called metastatic). The trial also will study the safety and side effects of the drug combination compared to the standard of care treatment. Other questions the trial aims to answer include:
1. Does TPST-1120 in combination with atezolizumab and bevacizumab improve the time that patients are alive and cancer is not growing (progression free survival) compared to atezolizumab and bevacizumab
2. Does TPST-1120 in combination with atezolizumab and bevacizumab improve the shrinking of cancer (the overall response rate) compared to atezolizumab and bevacizumab
Trial participants will be randomly assigned to take one of the following:
1. TPST-1120 3 tablets (600 mg) by mouth twice a day every day along with atezolizumab 1200 mg intravenously every 3 weeks and bevacizumab 15 mg/kg intravenously every 3 weeks
2. Placebo (look-alike that does not contain study drug) 3 tablets by mouth twice a day every day along with atezolizumab 1200 mg intravenously once every 3 weeks and bevacizumab 15 mg/kg intravenously once every 3 weeks
Trial participants will receive routine and trial-specific cancer care from their study doctor including
* visits to the clinic every 3 weeks for physical examination, labs and questions about health and symptoms
* measurement of their cancer by CT scan every 9 weeks.
Trial participants can stop study treatment at any time they choose and for any reason. They also can continue to receive study treatment for as long as the treatment is controlling cancer growth and they are tolerating the drug effects.

开始日期2025-12-01

申办/合作机构

Tempest Therapeutics, Inc.

100 项与贝伐珠单抗相关的临床结果

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100 项与贝伐珠单抗相关的转化医学

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100 项与贝伐珠单抗相关的专利（医药）

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23,217

项与贝伐珠单抗相关的文献（医药）

2026-04-01·DEN open

Long‐term results of palliative placement of very low‐axial force self‐expandable metallic stents for malignant colorectal obstruction

Article

作者: Moroi, Rintaro ; Kuwai, Toshio ; Yoshida, Shuntaro ; Enomoto, Toshiyuki ; Tomita, Masafumi ; Kyo, Rika ; Shiratori, Toshiyasu ; Saida, Yoshihisa ; Matsuzawa, Takeaki ; Isayama, Hiroyuki ; Sumida, Yorinobu ; Yamada, Tomonori ; Sasaki, Takashi

Abstract:

Objectives:

Stent placement is a standard option for palliative decompression in patients with malignant colorectal obstruction. Long‐term stent placement is associated with perforation, migration, and stent occlusion. Perforation is associated with life expectancy. Several studies have shown that stents with a high axial force (AF), which is defined as the force required to maintain the stent straight after it has bent, are associated with a higher perforation rate. Therefore, we evaluated the long‐term outcomes of using a very low AF stent (Niti‐S Enteral Colonic Uncovered stent D‐type) for palliative purposes.

Methods:

Eighty‐one consecutive patients with malignant colorectal obstruction in 33 medical institutions were evaluated. A stent with very low AF was placed using an endoscope system. We evaluated the adverse events (including perforation, migration, and stent occlusion), 1‐year survival rate, and cumulative patency rate. Univariate analysis was conducted using Fisher's exact test. The overall survival and cumulative patency rates were assessed using the Kaplan–Meier method.

Results:

The 1‐year cumulative survival rate was 37.8% after stent placement. The 3‐month, 6‐month, and 1‐year cumulative patency rates after stenting were 93.6%, 84.2%, and 75.8%, respectively. The major adverse events included stent migration (6.2%), stent occlusion (9.9%), and perforation (2.5%). Chemotherapy was administered in 26 cases (32.1%) after stenting, and bevacizumab was administered in five cases. However, no cases of perforation occurred following bevacizumab administration.

Conclusions:

Our results suggest that very low AF stents are safe and effective. Therefore, they may be a suitable option for applications, such as palliation. (UMIN 000011304)

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness analysis of regorafenib dose optimization for refractory metastatic colorectal cancer

Article

作者: Appukkuttan, Sreevalsa ; Cho, Sang Kyu ; Barzi, Afsaneh ; Grossman, Jamie ; Lee, Woojung ; Babajanyan, Svetlana ; Hocum, Brian ; Marian, Marisca ; Yang, Min ; Bekaii-Saab, Tanios

BACKGROUND:

New regimens have emerged as third-line or later therapies for metastatic colorectal cancer (mCRC), including regorafenib dose optimization (ReDO), trifluridine/tipiracil and bevacizumab (TAS-BEV) combination therapy, and fruquintinib. We evaluated relative cost-effectiveness of these therapies in patients with mCRC from a US payer's perspective.

MATERIALS AND METHODS:

A partitioned survival model (PSM) was constructed to estimate total costs and quality-adjusted life years (QALYs). Clinical parameters were obtained from pivotal trials of the respective therapies and incremental cost-effectiveness ratios (ICERs) were estimated to assess relative cost-effectiveness of these treatments. Model robustness was assessed using deterministic (DSA) and probabilistic sensitivity analysis (PSA). Three scenario analyses were conducted: (1) assuming equal efficacy across treatments, (2) with prior exposure to anti-vascular endothelial growth factor (VEGF) therapy, and (3) alternative clinical inputs for fruquintinib from a different clinical trial.

RESULTS:

Under the conventional willingness-to-pay (WTP) threshold in US ($150,000 per QALY gained), ReDO was cost-effective when compared with TAS-BEV and was dominant over fruquintinib. TAS-BEV was associated with an incremental QALY of 0.197 over ReDO, resulting in an ICER at $554,567 per QALY gained. The base case results were robust in DSA and PSA. Most influential parameters were treatment cost and effectiveness. In patients with prior anti-VEGF therapy, ReDO remained cost-effective compared to TAS-BEV and fruquintinib under the conventional WTP threshold.

LIMITATION:

Differences in trial populations may affect the comparability of the outcomes. Sensitivity and scenario analyses were conducted to address these limitations.

CONCLUSION:

ReDO was cost-effective compared with TAS-BEV from the US payer's perspective despite a higher QALY gain associated with TAS-BEV. ReDO was dominant over fruquintinib, consistently having a higher QALY gain and lower cost.

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Cost-efficiency and expanded access modeling of conversion to biosimilar bevacizumab in metastatic colorectal and non-squamous non-small cell lung cancer in Medicare

Article

作者: Bernauer, Mark ; Roth, Joshua A. ; Dorman, Stephanie ; Kratochvil, David

BACKGROUND:

Biosimilars to originator bevacizumab (Avastin), such as bevacizumab-bvzr (Zirabev), can deliver substantial savings and/or expanded access to biologic therapy for patients with metastatic colorectal (mCRC) and non-squamous non-small cell lung cancer (mNSCLC). The objective of this study is to explore the cost-efficiency and budget-neutral expanded access of bevacizumab-bvzr in mCRC and mNSCLC in Medicare.

METHODS:

We developed a Medicare payer perspective simulation model of patients treated for mCRC and mNSCLC to estimate cost-savings from converting bevacizumab (originator) to bevacizumab-bvzr or alternative biosimilars such as bevacizumab-awwb, -maly, and -abcd. The target patient population receiving annual first-line systemic therapy was calculated using Medicare enrollment data, SEER cancer incidence rates in patients age ≥65, and an assumption that 39.3% and 77.2% of new diagnoses receive systemic therapy for mCRC and mNSCLC respectively based on recent evidence. 76.0% of systemically treated mCRC patients and 11.4% of incident mNSCLC patients were expected to be treated with bevacizumab-based regimens based on recent evidence. Costs were derived from the 2024 Average Sales Price (ASP). Results include per-patient per-month (PPPM) cost savings (vs. originator), total monthly savings in the cohort, and number needed to convert (NNC) to biosimilar to fund the treatment of an additional 100 patients.

RESULTS:

PPPM savings from conversion to bevacizumab-bvzr were $4,205 in mCRC and $8,410 in mNSCLC. In 100% conversion scenarios, full cohort monthly savings were $27,664,432 in mCRC (n = 6,579) and $32,319,323 in mNSCLC (n = 3,843), respectively. At 100% conversion, monthly savings from biosimilar conversion could fund up to 13,887 additional mCRC patient-months of treatment with bevacizumab-bvzr + FOLFOX, and up to 8,959 additional mNSCLC patient-months of treatment with bevacizumab-bvzr + paclitaxel + carboplatin. In mCRC and mNSCLC the biosimilar NNC from the originator was 47 and 43, respectively. The biosimilar NNC from other biosimilars ranged from 60-4,564 and 55-4,422 for mCRC and NSCLC, respectively.

CONCLUSION:

In the first cost-efficiency and expanded access study of biosimilar bevacizumab in mCRC and mNSCLC, we find that bevacizumab-bvzr-based regimens can result in substantial cost savings relative to originator-based first line treatment in Medicare. These cost savings could be reinvested to treat a substantial number of additional patients with mCRC or mNSCLC, or fund other costs of care in Medicare, on a budget-neutral basis.

3,006

项与贝伐珠单抗相关的新闻（医药）

2025-09-09

·PRNewswire

Dizal Showcases Robust Portfolio of Lung Cancer Studies at 2025 WCLC

SHANGHAI, Sept. 9, 2025 /PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced the presentation of new findings on its leading assets, ZEGFROVY® (sunvozertinib) and golidocitinib, in non-small cell lung cancer (NSCLC) at the 2025 World Conference on Lung Cancer (WCLC), held September 6–9 in Barcelona, Spain. ZEGFROVY: Targeting EGFR exon20ins and a wide spectrum of EGFR mutations The latest data from the multinational pivotal WU-KONG1 Part B (WU-KONG1B) study for ZEGFROVY were presented in an oral session at the conference and simultaneously published in the Journal of Clinical Oncology. Based on results from WU-KONG1B, ZEGFROVY received accelerated approval from the U.S. Food and Drug Administration (FDA) in July 2025 as the only targeted oral therapy for NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins). ZEGFROVY demonstrated a favorable benefit/risk profile in patients with platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The study showed robust and durable antitumor activity with a manageable safety profile. (#MA08.01). In addition to the oral presentation, multiple studies of ZEGFROVY were presented at the WCLC, highlighting its potential across a broad range of NSCLC patients, including those with EGFR exon20ins across all lines of therapy, uncommon EGFR and HER2 mutations, EGFR-sensitive mutation and co-mutations, and EGFR mutations resistant to EGFR TKIs. Both monotherapy and combination regimens were evaluated. In EGFR exon20ins NSCLC, ZEGFROVY demonstrated promising antitumor efficacy and a tolerable safety profile across first- and second- line, as well as adjuvant and neoadjuvant treatment settings. ZEGFROVY combined with anlotinib achieved an objective response rate (ORR) of over 80% and a disease control rate (DCR) of 100% in treatment-naïve EGFR exon20ins NSCLC (#P3.12.43). In previously treated patients, ZEGFROVY combined with bevacizumab achieved a DCR of 100%, with target tumor lesion shrinkage observed in 85.7% of patients. With a median follow-up of 15.2 months, the median duration of response (DoR) was 19.1 months, and three patients (3/14) remained in response at the data cut-off (#P2.10.13). Real-world cases supported the potential of ZEGFROVY in early- and advanced- stage NSCLC patients with EGFR exon20ins. As a neoadjuvant therapy, ZEGFROVY showed encouraging clinical benefit, with all 3 patients achieving an obvious partial response (PR) before surgery. (#EP.07.49). In the adjuvant setting, ZEGFROVY showed sustained efficacy and tolerable safety profiles, helping patients successfully pass the 1-year after surgery, a peak period for disease recurrence (#EP.07.55). In the first-line maintenance setting, ZEGFROVY showed sustained efficacy and safety in lung adenocarcinoma patients who were intolerant to immunotherapy and chemotherapy (#EP.12.47). In NSCLC patients harboring uncommon EGFR mutations, ZEGFROVY combined with anlotinib demonstrated promising efficacy, including one patient who achieved complete remission of intracranial lesions (#P3.12.43). In a separate real-world case series, ZEGFROVY exhibited clinical efficacy in advanced NSCLC with HER2 exon20ins, with tumor shrinkage obviously observed post-prior treatment failures (#EP.12.46). In treatment-naïve NSCLC patients with EGFR-sensitive mutation and co-mutations, ZEGFROVY in combination with anlotinib achieved an ORR of 77.8% and a DCR of 100% (#P3.12.22). In NSCLC patients with EGFR mutations who failed prior EGFR-TKI therapies, ZEGFROVY, both as monotherapy (#EP.12.43) and in combination with chemotherapy (#P3.12.47), was well tolerated and demonstrated encouraging antitumor activity. Golidocitinib: Janus kinase 1 (JAK1) only inhibitor Plus Anti-PD-1 in Anti-PD-1 Treated Advanced NSCLC Resistance to first-line immune checkpoint inhibitors (ICIs) in non-small cell lung cancer (NSCLC) leads to limited treatment options and poor prognosis. Preclinical and early clinical data have shown synergistic effects between JAK inhibitors and anti-PD-1, suggesting a promising therapeutic strategy in this population. Golidocitinib in combination with anti-PD-1 was being evaluated in immune-resistant NSCLC patients. The study showed a well-tolerated profile, with no DLTs observed in the dose-escalation phase. Ongoing enrollment and data collection will provide deeper insights into clinical utility of golidocitinib (#P1.11.74). Dr. Xiaolin Zhang, CEO of Dizal, remarked, "Dizal is advancing therapies for patients with NSCLC across EGFR exon 20 insertion, uncommon and EGFR-sensitizing mutations to address significant unmet medical needs. Through scientific innovation, we aim to deliver safe, effective and transformative treatments to patients worldwide." - End - About ZEGFROVY®(sunvozertinib) ZEGFROVY is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. ZEGFROVY is approved in the U.S. and China for the treatment the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), whose disease has progressed on or after platinum-based chemotherapy. The China approval is based on the results of the pivotal WU-KONG6 study in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The U.S. approval is supported by WU-KONG1Part B, a multinational pivotal study investigating the efficacy and safety of ZEGFROVY in the same indication. In addition, ZEGFROVY also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations (such as G719X, L861Q, etc.), as well as HER2 exon20ins. ZEGFROVY showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable. WU-KONG28, a phase III, multinational, randomized study assessing ZEGFROVY as a first-line treatment for patients with EGFR exon20ins NSCLC, has completed enrollment across 16 countries and regions. Pre-clinical and clinical results of ZEGFROVY were published in peer-reviewed journals Cancer Discovery, The Lancet Respiratory Medicine and Journal of Clinical Oncology. About golidocitinib (DZD4205) Golidocitinib is currently the first and only Janus kinase 1 (JAK1) selective inhibitor being evaluated for the treatment of r/r PTCL. In June 2024, golidocitinib was approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL). At the data cut-off date of August 31, 2023, golidocitinib has demonstrated robust and durable anti-tumor efficacy, with an ORR of 44.3%. All subtypes benefited well, and the ORR of common subtypes exceeded 40%. More than 50% of the patients with tumor remission achieved a complete response with a CRR of 23.9%. Per IRC assessment, the median duration of response (mDoR) reached 20.7 months. As of February 2024, golidocitinib showed a median overall survival (mOS) of 24.3 months. Golidocitinib was granted Fast Track Designation by the U.S. FDA for the treatment of r/r PTCL in February 2022. In September 2023, the CDE accepted its NDA and granted Priority Review for the treatment of r/r PTCL. The Phase I clinical data of golidocitinib (JACKPOT8 PART A) were published in Annals of Oncology (Impact Factor: 51.8), and global pivotal trial data of golidocitinib for the treatment of r/r PTCL (JACKPOT PART B) were published in The Lancet Oncology (Impact Factor: 54.4). About Dizal Dizal is a biopharmaceutical company, dedicated to the discovery, development and commercialization of differentiated therapeutics for the treatment of cancer and immunological diseases. The company aims to develop first-in-class and groundbreaking new medicines, and further address unmet medical needs worldwide. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio with multiple assets in global pivotal studies and two leading assets: ZEGFROVY, approved in both the U.S. and China, and golidocitinib, approved in China. To learn more about Dizal, please visit , or follow us on Linkedin or X. Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", and "intend" and similar expressions, as they relate to Dizal, are intended to identify certain forward-looking statements. Dizal does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections, and understandings of the management of Dizal with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties, and other factors, some of which are beyond Dizal's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Dizal's competitive environment, and political, economic, legal, and social conditions. Dizal, the Directors, and the employees of Dizal assume (a) no obligation to correct or update the forward-looking statements contained on this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turnout to be incorrect. Contacts Investor Relations: [email protected] Business Development: [email protected] Media Contact: [email protected] SOURCE Dizal Pharmaceutical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果临床3期免疫疗法上市批准优先审批

2025-09-08

·ioncology

【述评】肝细胞癌的新辅助治疗：现状与展望

GUIDE编者按在我国肝细胞癌（HCC）高发且初诊可切除率不足20%、术后5年复发率高达70%的严峻背景下，赵磊教授的述评直面新辅助治疗循证证据匮乏的核心挑战，系统阐释了免疫检查点抑制剂（ICI）联合靶向或局部治疗（如放疗）通过利用原发肿瘤抗原库激发持续抗肿瘤免疫的协同机制，填补了当前指南在优化围手术期策略的理论空白；基于作者团队领衔的notable-HCC等前沿研究，赵磊教授创新性提出“夹心模式”（新辅助+术后辅助）在筛选敏感人群及降低复发中的独特价值，并为早期HCC患者的分层治疗提供循证框架，同时批判性剖析适应人群界定、疗效预测标志物缺失等痛点，强调高质量随机对照试验对验证长期生存获益的迫切性—本文不仅是推动HCC新辅助治疗从概念探索转向临床实践的关键里程碑，更为全球免疫联合治疗范式提供了“中国智慧”的决策蓝本。扫码或点击下方链接阅读下载全文doi: 10.7659/j.issn.1005-6947.250404专家介绍：赵磊，山东第一医科大学附属肿瘤医院（山东省肿瘤医院）/新疆医科大学附属肿瘤医院主任医师，主要从事肝胆胰肿瘤外科临床治疗与基础方面的研究。肝细胞癌的新辅助治疗：现状与展望赵磊1,2[1.山东第一医科大学附属肿瘤医院（山东省肿瘤医院）肝胆外科，山东济南 250117；2. 新疆医科大学附属肿瘤医院，新疆乌鲁木齐 830000]摘要肝细胞癌（HCC）在我国及全球均高发，初诊可行根治性切除者不足20%，且术后5年复发率高达70%。围手术期治疗是降低复发的重要策略，但HCC的新辅助治疗循证证据有限。近年来，免疫检查点抑制剂（ICI）为代表的免疫治疗在HCC治疗中取得进展，其在新辅助治疗中的潜力引起广泛关注。新辅助免疫治疗可利用原发肿瘤作为抗原库激发持续的抗肿瘤免疫，并结合靶向及局部治疗有望协同增效。现有早期研究提示其安全性与初步疗效，但适应人群选择、最佳联合模式及疗效预测指标仍待明确。未来需开展高质量随机对照试验，以验证其对长期生存的价值并优化治疗策略。关键词癌，肝细胞；肿瘤辅助疗法；免疫检查点抑制剂中图分类号：R735.7The neoadjuvant therapy of hepatocellular carcinoma: current status and prospectsZHAO Lei1,2[1. Department of Hepatobiliary Surgery, Shandong Cancer Hospital Affiliated to First Medical University, Ji'nan 250117, China; 2. Xinjiang Cancer Hospital Affiliated to Xinjiang Medical University, Urumqi 830000, China]Abstract Hepatocellular carcinoma (HCC) remains highly prevalent in China and worldwide, with less than 20% of newly diagnosed patients eligible for radical resection and a postoperative 5-year recurrence rate as high as 70%. Perioperative therapy is a key strategy to reduce recurrence, yet evidence for neoadjuvant therapy in HCC is still limited. In recent years, immune checkpoint inhibitors (ICIs) have shown significant progress in HCC treatment, and their potential in the neoadjuvant setting has attracted growing attention. Neoadjuvant immunotherapy can utilize the primary tumor as an antigen reservoir to induce sustained antitumor immunity, and its combination with targeted agents or local therapies may yield synergistic effects. Early studies have demonstrated acceptable safety and preliminary efficacy; however, optimal patient selection, ideal combination strategies, and reliable predictive biomarkers remain to be established. High-quality randomized controlled trials are warranted to verify its impact on long-term survival and to optimize treatment approaches.Key words Carcinoma, Hepatocellular; Neoadjuvant Therapy; Immune Checkpoint InhibitorsCLC number: R735.7肝细胞癌（hepatocellular carcinoma，HCC）在我国仍属常见、高发恶性肿瘤，2022年新发病例近37万，位居恶性肿瘤第4位；而死亡病例数近32万，仅次于肺癌，居第2位[1]。近年来，以靶向药物（targeted therapy）和免疫检查点抑制剂（immune checkpoint inhibitors，ICI）为代表的系统治疗在HCC治疗中取得显著进展，但单纯系统治疗难以达到长期生存或治愈的效果。2019—2021年，国内酪氨酸激酶抑制剂（tyrosine kinase inhibitors，TKI）与ICI应用已较为普遍，但同期HCC患者的5年总生存（overall survival，OS）率仍无明显提高，仅为14.4%[2]。HCC的治愈仍主要依靠以根治性切除为主的外科与局部治疗。我国HCC外科治疗中，长期存在一“低”一“高”两个难点，成为提升预后的主要障碍。一“低”是指初诊患者整体可切除率低，一般仅20%左右，本中心数据与此基本符合[3-4]。近年来国内学者广泛开展转化治疗（conversion therapy），使部分初始不可切除HCC患者重新获得根治性切除机会，其中更有患者获得长期生存乃至治愈；本中心在HCC转化治疗的理论[5-6]与实践[3-4,7]方面也有积极探索。一“高”则是指获得根治性切除的HCC患者中，术后复发率高，整体术后5年复发率可达70%；临床中降低恶性肿瘤根治术后复发率，主要思路为围手术期治疗，即一“前”一“后”的新辅助治疗（neoadjuvant therapy）及辅助治疗（adjuvant therapy）。相较于虽屡经波折，但已完成或正在开展多项Ⅲ期随机对照临床研究（randomized controlled trials，RCT）的辅助治疗[8]，HCC的新辅助治疗仍处于较为初步的探索阶段，但已在某些方面展现出令人期待的前景。“新辅助治疗”的概念，最早于20世纪80年代，由联合化疗的奠基人，美国国立癌症研究所的Frei教授[9]针对手术前的化疗提出。甫一提出时，新辅助化疗的概念就包含两重目标：使原发瘤退缩至外科切除更有效的大小或分期，或早期治疗微转移，或二者皆有。从外科治疗角度，容易更重视后一目标；而新辅助治疗的最终目标，与其他所有抗肿瘤治疗的手段及方法并无不同，均为最终提高患者生存或生活质量，而非单单以手术切除为最终目标。相较于在手术完成后进行的辅助治疗，在手术开始之前进行的新辅助治疗，有其潜在的风险，最主要的就是患者对于治疗不敏感，出现肿瘤进展，使手术困难甚至失去根治性切除的机会；其他风险还有治疗相关不良反应导致手术延迟或增加手术并发症发生风险，为获取病理诊断进行的术前穿刺活检也会带来额外的相关风险等。但另一方面，新辅助治疗相较于辅助治疗也有其优势：治疗敏感的患者可提高可切除性，降低手术范围及难度，减小手术创伤；在错配修复缺陷的局部进展期直肠癌患者中，抗细胞程序性死亡受体1（programmed death 1，PD-1）药物dostarlimab的新辅助治疗使近80%的患者豁免了立即手术[10]。新辅助治疗中，因为靶病灶存在，可以直观、迅速、高效地评价治疗反应，从而识别治疗敏感患者，以替代指标（surrogate predictors）判断预后；及时终止或调整无效治疗，延续有效治疗；因可以获得治疗后切除的手术标本，使对系统治疗与转化治疗的病理评估得以实现。在高级别尿路上皮癌中，接受新辅助与辅助治疗的患者预后相似，无明显差异；但在新辅助治疗中，根据对于治疗的应答与否，可以显著区分预后良好与预后不佳的患者[11]，而这一点无法通过辅助治疗达到。直肠癌中，经术前新辅助放化疗后由cT3N0/1降至ypT2N0的患者，预后甚至显著优于直接切除的cT2N0患者[12]。仔细分析这一结果：新辅助后降期至T2N0的患者，与初始T2N0的患者在切除时，肿瘤负荷位于同一基线水平，但显示出更好的预后；这提示新辅助治疗的意义，不仅在于对肿瘤的物理降期，还在于通过肿瘤应答情况，筛选出了生物学行为相对较好的亚群患者。因为有效系统治疗药物出现较晚，HCC新辅助治疗的探索还要晚于其他恶性肿瘤，目前尚无高级别循证医学证据（如Ⅲ期RCT研究）证明其有效性，但近年来开始有初步的早期、小样本研究结果报道。其中以下几个方向的问题，临床意义显著，讨论也较多。1 HCC新辅助治疗中系统治疗药物选择HCC系统治疗中，TKI靶向治疗远早于ICI；nivolumab在2017年被美国食品药品管理局批准用于HCC的二线治疗，晚于sorafenib10年，彼时HCC系统治疗的一线推荐仍为lenvatinib和sorafenib，但HCC中新辅助治疗的报道，却首先见于ICI。2022年，The Lancet Gastroenterology & Hepatology同期发表2篇[13-14]均启动于2017年早期临床研究，初步证实PD-1单药或联合CTLA-4用于HCC新辅助治疗的安全性与有效性。为何ICI用于新辅助治疗首先受到了更多的关注？化疗、靶向治疗均为直接杀伤残余肿瘤细胞；作为新辅助治疗，如前所述，作用仅限于对肿瘤的物理杀伤及生物学行为筛选，其作用不会直接持续至术后。而免疫治疗是激发机体的抗肿瘤免疫，这一效应可能至术后持续存在，因而免疫新辅助治疗理论上更具合理性。在非小细胞肺癌围手术期治疗的CheckMate 77T研究[15]，经术前新辅助治疗均达完全病理缓解（pathologic complete response，pCR）的患者中，化疗加PD-1达pCR较单纯化疗达pCR的患者预后仍显著更好，提示免疫治疗带来了除物理杀伤肿瘤细胞及生物学筛选以外的获益，推测可能与抗肿瘤免疫有关。与单纯术后辅助治疗相比，后者是在切除原发肿瘤后针对微转移的抗肿瘤治疗。与此不同，新辅助治疗（尤其是免疫治疗）是在原发肿瘤存在的情况下进行。在机制上，新辅助治疗使用原发肿瘤作为抗原来源，来刺激抗原-抗体反应，而抗肿瘤免疫反应取决于T细胞、抗原递呈细胞和肿瘤细胞之间的相互作用。当存在大量原发肿瘤（含有免疫治疗靶向的抗原）时，这种免疫反应将会更强。黑色素瘤中，与辅助治疗相比，新辅助免疫治疗可以更有效地促进T细胞介导的免疫的从头诱导、预先存在的抗肿瘤T细胞的扩张以及更多样化的肿瘤特异性T细胞库的发育[16]。目前国内外单独或联合使用抗PD-（L）1抗体进行新辅助治疗已在多种肿瘤中显示出令人鼓舞的初步结果，ICI目前是HCC新辅助研究中系统治疗的基础。2 HCC新辅助治疗中联合局部治疗的意义转化治疗中，肿瘤能否显著降期或缩小是能否成功转化的关键，因此局部治疗非常重要。对于新辅助治疗，肿瘤在治疗初始即为可切除（resectable），治疗目的并不直接在于缩小肿瘤，而是减少术后复发；因此系统治疗在新辅助治疗中意义更显著，联合局部治疗可更好地避免肿瘤进展至不可切除，而这正是新辅助治疗的主要风险之一。在靶免治疗到来之前，HCC的新辅助治疗主要依靠介入（transarterial chemo-embolization，TACE）、放疗等局部治疗。我国权威指南不推荐对于可切除HCC的术前介入治疗；而伴门脉癌栓HCC的术前放疗则显示出生存获益[17]。新近肝动脉灌注化疗（hepatic arterial infusion chemotherapy，HAIC）用于单个较大HCC新辅助治疗也有报道[18]。在免疫新辅助治疗的基础上，如何结合、结合何种局部治疗更为合理？免疫结合局部的新辅助治疗，不应是简单地随意组合，更不能单纯为提高肿瘤应答而一味叠加不同治疗方法；理想的局部治疗手段，应能促进免疫治疗的效果，或克服对免疫治疗的不敏感，从而产生“1+1>2”的效果，即协同增效。在多个瘤种中，放疗显示出这一效应[19]。本中心完成的早期HCC探索性notable-HCC研究中，经过立体定向放疗（stereotactic body radiotherapy，SBRT）联合PD-1新辅助治疗后，肿瘤微环境中的免疫浸润模式发生显著变化：各亚型T细胞在治疗后普遍性显著增加；固有免疫相关细胞，特别是树突状细胞也显著增加。同时，新辅助治疗后T细胞激活相关基因的表达显著上调，肿瘤反应性T细胞、细胞毒性细胞免疫评分显著升高。T细胞受体检测显示新辅助治疗后新产生的T细胞克隆型的比例显著增加，新产生的克隆型主要是大克隆型，超扩增克隆型较少。以上结果均提示，经过免疫加放疗后，抗肿瘤免疫得到显著增强，且与肿瘤应答程度正相关[20]。此后在进展期HCC中的研究也得到类似结果[21]。证明免疫结合放疗在HCC新辅助治疗中的临床意义，尚需要高级别的循证医学证据。此外，HAIC、TACE等与免疫联合用于HCC新辅助治疗也有临床研究正在进行中。3 何种分期的HCC适合新辅助治疗我国《原发性肝癌诊疗指南（2024年版）》[22]支持具有术后高危复发转移风险的患者进行新辅助治疗，因此在相对进展期的患者推荐更积极，但其推荐的可考虑新辅助治疗的分期，较《原发性肝癌诊疗指南（2022年版）》已有前移，如中国肝癌分期（CNLC）Ⅰb期。而在进展期的Ⅱb、Ⅲa期[巴塞罗那分期（BCLC）B~C期]，国际上更多归于初始不可切除，因此新辅助治疗与转化治疗的界限已相当模糊，难以明确界定。早期HCC依据国内外指南均推荐手术治疗，因此其术前治疗的“新辅助”性质更为明确。HCC预后相对较差，根治性切除术后复发率高，即使BCLC 0~A期（即CNLC Ⅰ期）的早期HCC，术后1年复发率也超过1/4，而术后3年复发率更超过一半[23]；因此，即使是早期HCC，术后复发问题也仍远未解决，探索新辅助治疗也符合临床需要。相对于临界可切除的肿瘤，早期HCC行新辅助治疗有较大的“容错空间”：即使肿瘤对新辅助治疗应答不佳，出现一定程度的进展，仍不致完全失去手术根治机会。早期HCC进行新辅助治疗的研究也有其他有利因素，如患者一般情况、器官功能状态、肝脏功能储备均较好，可以更好地耐受新辅助治疗；而机体相对正常的免疫状态，也有利于激发更好的抗肿瘤免疫；肿瘤负荷相对较轻，局部治疗引起的肿瘤坏死等改变，不至于产生较严重的全身系统反应；治疗相关不良反应发生率及耐受性均较好。4 HCC新辅助治疗疗效的预测指标如前所述，新辅助治疗的优势之一就在于靶病灶的存在，可以迅速、直接地反映治疗效果、筛选治疗敏感人群。最常用于评估疗效的是基于影像学的实体肿瘤反应评价标准（response evaluation criteria in solid tumours，RECIST），改良实体瘤疗效评估标准（modified RECIST，mRECIST）等标准；临床也使用肿瘤标志物的变化评估对于治疗的应答，此外还有对于切除标本中肿瘤坏死程度的病理评估。影像学反映的肿瘤体积（RECIST）或有血供的活性部分体积（mRECIST）的变化，以及标志物反映的有活性肿瘤细胞的变化，本质上体现的都是对于肿瘤的直接杀伤程度，即直接疗效；实际上，新辅助治疗真正预期的疗效，应体现于术后转移复发率的降低。目前观察到，以上指标反映的直接疗效与新辅助术后患者的生存相关，即经新辅助治疗达到客观缓解（包括pCR与部分缓解）的患者，术后预后优于未达客观缓解的患者，因此仍多以上述指标评估新辅助疗效。对于新辅助免疫治疗，其效应不仅在于直接杀伤肿瘤，更在于借助存在的肿瘤抗原，激发有效抗肿瘤免疫，延续至术后持续存在，以预防复发转移。因此，即使肿瘤体积或活性范围尚未出现明显缩小，如肿瘤微环境内已出现抗肿瘤免疫的增强，如免疫活性细胞浸润增多，甚至更早于此的相关基因表达的升高，也可能提示新辅助免疫治疗的良好疗效。未来如能通过外周血检测或功能分子影像技术反映肿瘤微环境中抗肿瘤免疫细胞的数量、状态等指标，是否能成为更为敏感、准确的免疫新辅助疗效预测指标，也是可能的研究方向。5 HCC新辅助治疗模式：单纯新辅助模式与“夹心”模式新辅助治疗的优缺点，常常被与辅助治疗相比较；正如其名，一个瘤种的新辅助治疗也往往是在辅助治疗显示有效后进一步向术前的延伸。但新辅助治疗与辅助治疗并非绝对矛盾，而是有对立统一性。目前新辅助的临床研究，多采用术前新辅助治疗加术后辅助治疗的“夹心”模式，对比单纯的术后辅助治疗模式，来验证新辅助治疗的临床意义[24]。“夹心”模式理论上通过术后延续的免疫辅助治疗，来强化、保持术前新辅助免疫治疗形成的抗肿瘤免疫；另一方面，术前新辅助治疗也可筛选出适合继续接受术后辅助治疗的患者，即肿瘤应答良好的患者（responder），同时可以对新辅助治疗中出现严重免疫相关不良反应的患者停止术后继续辅助治疗，从而更好地保证辅助治疗的有效性与安全性。6 小结与展望关于HCC的新辅助治疗，目前我们未知的问题远远多于已知，而循证医学证据还非常有限；要回答这些未知问题，需要更多高水平的临床研究来提供证据。以下几个方向的突破尤其受到临床期待。6.1 证明HCC中新辅助治疗临床意义的循证医学证据HCC术后辅助治疗的Ⅲ期RCT研究尚未获得阳性结果，而新辅助治疗（或新辅助加辅助的“夹心”模式）还需证明相对于单纯辅助治疗的优效；且最有说服力的研究终点应为总生存而非无复发生存。6.2 获益人群的识别HCC一线ICI或TKI单药治疗的整体有效率均在20%左右；虽然在晚期一线治疗中也存在仅部分患者有效的问题，但对于可根治切除的HCC患者，“陪绑”接受新辅助治疗而无生存获益显然更不符合患者利益。目前临床多选择具有术后高危复发因素的患者考虑新辅助治疗，提高潜在的风险/获益比。对获益人群更为精准地筛选，有赖于对免疫等新辅助治疗机制的深入认识与疗效预测指标的研究。6.3 免疫联合治疗模式的确定单纯免疫治疗有效率较低，通过结合其他系统或局部手段进行联合新辅助治疗，以期增加获益人群范围；合理的联合治疗应具有协同增效作用。另一方面，治疗药物与方法的叠加，必然带来治疗相关副反应的增加，更应谨慎平衡手术风险、生存获益等因素。作者贡献声明：赵磊构思并撰写全文。利益冲突：作者声明不存在利益冲突。参考文献（在框内向上滑动手指即可浏览全部参考文献）[1]Han B, Zheng R, Zeng H, et al. Cancer incidence and mortality in China, 2022[J]. J Natl Cancer Cent, 2024, 4(1):47-53. doi:10.1016/j.jncc.2024.01.006.[2]Zeng H, Zheng R, Sun K, et al. Cancer survival statistics in China 2019-2021: a multicenter, population-based study[J]. J Natl Cancer Cent, 2024, 4(3):203-213. doi:10.1016/j.jncc.2024.06.005.[3]Zhang B, Shi X, Cui K, et al. Real-world practice of conversion surgery for unresectable hepatocellular carcinoma - a single center data of 26 consecutive patients[J]. BMC Cancer, 2023, 23(1):465. doi:10.1186/s12885-023-10955-7.[4]Chang Z, Li M, Sun Z, et al. Clinical study on conversion therapy of hepatocellular carcinoma - summary and comparison of clinical data from a single center of consecutive four years[J]. BMC Gastroenterol, 2024, 24(1):369. doi:10.1186/s12876-024-03457-8.[5]Zhao L, Zhao H. Conversion surgery for hepatocellular carcinoma in the New Era of targeted and immune checkpoint inhibitor therapies[J]. Hepatobiliary Surg Nutr, 2020, 9(6):809-811. doi:10.21037/hbsn-20-693.[6]Zhao L, Zhao H, Sun H. It's time to propose a uniform criteria for determining "clinical complete response" in hepatocellular carcinoma[J]. Hepatobiliary Surg Nutr, 2022, 11(4):620-622. doi:10.21037/hbsn-22-233.[7]Yalikun K, Li Z, Zhang J, et al. Hepatic artery infusion chemotherapy combined with camrelizumab and apatinib as conversion therapy for patients with unresectable hepatocellular carcinoma: a single-arm exploratory trial[J]. BMC Cancer, 2025, 25(1):838. doi:10.1186/s12885-025-14250-5.[8]Qin S, Chen M, Cheng AL, et al. Atezolizumab plus bevacizumab versus active surveillance in patients with resected or ablated high-risk hepatocellular carcinoma (IMbrave050): a randomised, open-label, multicentre, phase 3 trial[J]. Lancet, 2023, 402(10415):1835-1847. doi:10.1016/S0140-6736(23)01796-8.[9]Frei E 3rd. What's in a name--neoadjuvant[J]. J Natl Cancer Inst, 1988, 80(14):1088-1089. doi:10.1093/jnci/80.14.1088.[10]Cercek A, Foote MB, Rousseau B, et al. Nonoperative management of mismatch repair-deficient tumors[J]. N Engl J Med, 2025, 392(23):2297-2308. doi:10.1056/NEJMoa2404512.[11]Martini A, Falagario UG, Waingankar N, et al. Neoadjuvant versus adjuvant chemotherapy for upper tract urothelial carcinoma[J]. Urol Oncol Semin Orig Investig, 2020, 38(8):684.e9-684.e15. doi:10.1016/j.urolonc.2020.03.008.[12]Delitto D, George TJ Jr, Loftus TJ, et al. Prognostic value of clinical vs pathologic stage in rectal cancer patients receiving neoadjuvant therapy[J]. JNCI J Natl Cancer Inst, 2018, 110(5):460-466. doi:10.1093/jnci/djx228.[13]Kaseb AO, Hasanov E, Cao HST, et al. Perioperative nivolumab monotherapy versus nivolumab plus ipilimumab in resectable hepatocellular carcinoma: a randomised, open-label, phase 2 trial[J]. Lancet Gastroenterol Hepatol, 2022, 7(3):208-218. doi:10.1016/S2468-1253(21)00427-1.[14]Marron TU, Fiel MI, Hamon P, et al. Neoadjuvant cemiplimab for resectable hepatocellular carcinoma: a single-arm, open-label, phase 2 trial[J]. Lancet Gastroenterol Hepatol, 2022, 7(3):219-229. doi:10.1016/S2468-1253(21)00385-X.[15]Cascone T, Awad MM, Spicer JD, et al. Perioperative nivolumab in resectable lung cancer[J]. N Engl J Med, 2024, 390(19):1756-1769. doi:10.1056/nejmoa2311926.[16]Blank CU, Rozeman EA, Fanchi LF, et al. Neoadjuvant versus adjuvant ipilimumab plus nivolumab in macroscopic stage Ⅲ melanoma[J]. Nat Med, 2018, 24(11):1655-1661. doi:10.1038/s41591-018-0198-0.[17]Wei X, Jiang Y, Zhang X, et al. Neoadjuvant three-dimensional conformal radiotherapy for resectable hepatocellular carcinoma with portal vein tumor thrombus: a randomized, open-label, multicenter controlled study[J]. J Clin Oncol, 2019, 37(24):2141-2151. doi:10.1200/jco.18.02184.[18]Hu Z, Deng M, Fu Y, et al. Neoadjuvant hepatic arterial infusion of oxaliplatin, fluorouracil, and leucovorin for resectable single large hepatocellular carcinoma[J]. Int J Surg, 2025, 111(6):3850-3858. doi:10.1097/js9.0000000000002437.[19]Sharabi AB, Lim M, DeWeese TL, et al. Radiation and checkpoint blockade immunotherapy: radiosensitisation and potential mechanisms of synergy[J]. Lancet Oncol, 2015, 16(13):e498-e509. doi:10.1016/S1470-2045(15)00007-8.[20]Li Z, Liu J, Zhang B, et al. Neoadjuvant tislelizumab plus stereotactic body radiotherapy and adjuvant tislelizumab in early-stage resectable hepatocellular carcinoma: the Notable-HCC phase 1b trial[J]. Nat Commun, 2024, 15:3260. doi:10.1038/s41467-024-47420-3.[21]Pan H, Zhou L, Cheng Z, et al. Perioperative Tislelizumab plus intensity modulated radiotherapy in resectable hepatocellular carcinoma with macrovascular invasion: a phase Ⅱ trial[J]. Nat Commun, 2024, 15:9350. doi:10.1038/s41467-024-53704-5.[22]中华人民共和国国家卫生健康委员会医政司. 原发性肝癌诊疗指南（2024 年版）[J]. 中国普通外科杂志, 2024, 33(4):475-530. doi:10.7659/j.issn.1005-6947.2024.04.001.Department of Medical Administration, National Health Commission of the People's Republic of China. Guidelines for the diagnosis and treatment of primary liver cancer (2024 edition) [J]. China Journal of General Surgery, 2024, 33(4):475-530. doi:10.7659/j.issn.1005-6947.2024.04.001.[23]Li C, Wang H, Chen R, et al. Outcomes and recurrence patterns following curative hepatectomy for hepatocellular carcinoma patients with different China liver cancer staging[J]. Am J Cancer Res, 2022, 12(2):907-921.[24]Llovet JM, Pinyol R, Yarchoan M, et al. Adjuvant and neoadjuvant immunotherapies in hepatocellular carcinoma[J]. Nat Rev Clin Oncol, 2024, 21(4):294-311. doi:10.1038/s41571-024-00868-0. （本文编辑熊杨）本文引用格式：赵磊. 肝细胞癌的新辅助治疗：现状与展望[J]. 中国普通外科杂志, 2025, 34(7):1347-1352. doi：10.7659/j.issn.1005-6947.250404Cite this article as: Zhao L. The neoadjuvant therapy of hepatocellular carcinoma: current status and prospects[J]. Chin J Gen Surg, 2025, 34(7):1347-1352. doi: 10.7659/j.issn.1005-6947.250404排版黎明梅初审熊杨复审宋涛终审姜晖版权声明本文为《中国普通外科杂志》原创文章，版权归中国普通外科杂志所有。其他媒体、网站、公众号等如需转载本文，请联系本刊编辑部获得授权，并在文题下醒目位置注明“原文刊发于《中国普通外科杂志》，卷（期）：起止页码”。谢谢合作！

2025-09-08

·PRNewswire

Breakthrough Therapy Designations Surge as $50B Cancer Drug Partnerships Reshape Market

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Sept. 8, 2025 /PRNewswire/ -- USA News Group News Commentary – The FDA's unprecedented wave of Breakthrough Therapy Designations through August has accelerated development timelines for life-saving cancer treatments[1], while major pharmaceutical companies deployed several multi-billion-dollar strategic partnerhips (with one topping $11 billion) to secure next-generation immunotherapies[2]. These recent designations are creating momentum for companies advancing breakthrough oncology platforms including Oncolytics Biotech Inc. (NASDAQ: ONCY), HUTCHMED (China) Limited (NASDAQ: HCM), CG Oncology, Inc. (NASDAQ: CGON), C4 Therapeutics, Inc. (NASDAQ: CCCC), and IDEAYA Biosciences, Inc. (NASDAQ: IDYA). Industry analysts expect the antibody-drug conjugate market to reach $50 billion by 2030[3], driven by 16 approved therapies and accelerating clinical pipelines. Immuno-oncology revenues jumped from $94 billion to $109.39 billion in 2025 alone[4], as leading institutions recognize the transformative potential of precision-targeted therapies and combination treatment approaches for previously untreatable cancers. Oncolytics Biotech Inc. (NASDAQ: ONCY) has announced impressive clinical data in metastatic colorectal cancer that could accelerate the company's path to registration. The latest results show pelareorep achieved a median progression-free survival of 16.6 months compared to just 5.7 months with standard treatments, representing approximately 2.5 times longer disease control in KRAS mutant colorectal cancer patients. Even more striking, overall survival reached 27.0 months versus the typical 11.2 months, representing a dramatic improvement in one of oncology's most challenging areas. This data comes from the REO 022 trial testing pelareorep with FOLFIRI and bevacizumab in second-line treatment. "These studies validate pelareorep's mechanism of action and present a clear opportunity to accelerate the pursuit of a registration-enabled study in the underserved KRAS mutant subset of mCRC patients," said Jared Kelly, CEO of Oncolytics. "Given pelareorep's activity in this difficult-to-treat cancer and other RAS-mutated gastrointestinal ("GI") tumors, including metastatic pancreatic and anal cancers, we believe pelareorep is positioned to become the premier platform immunotherapy in the GI space." The company plans to work with regulators to define a path toward registration in KRAS mutant colorectal cancer. The results extend beyond survival numbers. Translational studies confirmed pelareorep actually replicates inside tumor cells while activating immune responses, including dendritic cell maturation and CD8+ T cell activation. This proves the drug's ability to transform "cold" tumors into "hot" targets responsive to immunotherapeutic treatments. Pelareorep represents a systemically delivered oncolytic virus that reprograms the immune system against cancer. Unlike traditional chemotherapy that attacks cells indiscriminately, this immunotherapy selectively targets cancer while mobilizing the body's natural defenses. The company is simultaneously advancing toward registration-enabling trials in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC), where survival data proved equally compelling. Clinical results showed a 21.9% two-year overall survival rate compared to the 9.2% historical benchmark for standard chemotherapy protocols. Importantly, pelareorep demonstrated a 62% objective response rate when combined with chemotherapy and checkpoint inhibitors. This matters because checkpoint inhibitors currently lack approval for pancreatic cancer, suggesting pelareorep may unlock immunotherapy effectiveness in historically resistant tumors. Oncolytics recently provided updated safety data for pelareorep, which has been administered to over 1,200 patients across multiple studies. The most common side effects remain mild flu-like symptoms, with data showing pelareorep doesn't modify the safety profile of established chemotherapy regimens. The company confirmed ongoing discussions with the U.S. Food and Drug Administration (FDA) to finalize pivotal study parameters for pancreatic cancer, targeting potential trial initiation activities by Q4 2025. Pelareorep holds both Fast Track and Orphan Drug designations from the FDA for pancreatic cancer, facilitating expedited review processes. Recent leadership changes reflect an execution-focused approach. CEO Jared Kelly and Chief Business Officer Andrew Aromando both contributed to Ambrx Biopharma's US$2 billion acquisition by Johnson & Johnson. Oncolytics eliminated its At-the-Market and Equity Line financing facilities, suggesting confidence in current cash resources to reach key development milestones. With survival benefits approaching 3× standard care in colorectal cancer and regulatory discussions advancing for pancreatic cancer trials by Q4 2025, Oncolytics appears positioned at a critical inflection point where proof-of-concept has evolved into potential registration-enabling studies. The company's dual-track approach in gastrointestinal cancers, combined with an experienced leadership team and FDA Fast Track designation, suggests pelareorep may soon transition from clinical promise to commercial reality. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: HUTCHMED (China) Limited (NASDAQ: HCM) highlighted clinical data from multiple oncology studies at the 2025 World Conference on Lung Cancer and CSCO Annual Meeting, showcasing updated analysis from savolitinib's SACHI, SAVANNAH and Phase IIIb confirmatory studies in non-small cell lung cancer patients. The company will present first-time clinical data of HMPL-653, a novel CSF-1R inhibitor, from a Phase I study in patients with tenosynovial giant cell tumor. Savolitinib, an oral and highly selective MET tyrosine kinase inhibitor being jointly developed with AstraZeneca, continues advancing through multiple clinical programs targeting various lung cancer indications. According to Hutchmed's announcement, updated analysis from savolitinib's SACHI, SAVANNAH and a Phase IIIb confirmatory study in non-small cell lung cancer patients will be presented at WCLC 2025. The comprehensive clinical program spans investigator-initiated studies of fruquintinib and surufatinib across multiple cancer types, with HUTCHMED positioning itself as an innovative commercial-stage biopharmaceutical company committed to bringing targeted therapies from in-house discovery to patients worldwide. The company has successfully marketed its first three medicines in China, with its lead compound also approved globally, including in the US, Europe and Japan. CG Oncology, Inc. (NASDAQ: CGON) continues to demonstrate best-in-disease durability with its cretostimogene immunotherapy, reporting an additional 12 patients achieving complete response at 24 months in the BOND-003 Cohort C study. The robust 24-month complete response rate of 41.8% observed in 46 out of 110 patients with high-risk non-muscle invasive bladder cancer unresponsive to BCG treatment represents unprecedented durability in this heavily pretreated patient population. Notably, 90% of 12-month responders remained disease-free at 24 months, while 96.6% of patients were free from progression to muscle-invasive disease at 24 months. "Based on the latest data cut, I remain very encouraged that if approved, cretostimogene will represent an important, bladder-sparing advancement in the management of high risk non-muscle invasive bladder cancer in patients who have disease that is unresponsive to BCG," said Trinity J. Bivalacqua, MD, PhD, Urologic Oncology at Penn Medicine and Co-Director, Genitourinary Cancer Service Line, Abramson Cancer Center. "In my clinical experience, bladder cancer patients are seeking treatment options that offer durable and sustained results." The company is preparing to initiate its BLA submission for cretostimogene in the fourth quarter of 2025, with the Phase 3 BOND-003 Cohort C representing the largest study in this patient population to date. Cretostimogene's safety profile remains consistent with no Grade 3 or greater treatment-related adverse events or deaths reported, supporting its potential as a breakthrough backbone treatment for bladder cancer patients. C4 Therapeutics, Inc. (NASDAQ: CCCC) completed enrollment and dose escalation for its Phase 1 trial of cemsidomide in multiple myeloma, with the investigational MonoDAC degrader continuing to demonstrate a well-tolerated safety profile and compelling response rates. The company will present comprehensive data from all safety and efficacy evaluable multiple myeloma patients across all dose levels studied in the cemsidomide with dexamethasone cohort at the International Myeloma Society Annual Meeting on September 20, 2025. Cemsidomide is designed as a more potent and selective degrader of IKZF1/3 transcription factors that drive multiple myeloma and non-Hodgkin's lymphomas, with unique pharmacokinetic properties and demonstrated anti-myeloma activity and immunomodulatory effects. C4 Therapeutics will host an investor webcast on September 20, 2025, at 3 PM ET to highlight the data presentation and provide additional detail on the planned next steps of clinical development. The company is progressing its TORPEDO platform to efficiently design and optimize small-molecule degrader medicines targeting difficult-to-treat diseases, with cemsidomide representing a key advancement in harnessing the body's natural protein recycling system. IDEAYA Biosciences, Inc. (NASDAQ: IDYA) enrolled their first patient with non-small cell lung cancer in the ongoing Phase 1/2 combination trial of IDE397 and Trodelvy® in patients with MTAP-deletion solid tumors, expanding beyond the initial focus on MTAP-deletion urothelial cancer. IDE397, a potential first-in-class small molecule MAT2a inhibitor, is being combined with Gilead's Trop2-directed antibody-drug conjugate Trodelvy under a clinical study collaboration and supply agreement. MTAP-deletion is found in up to 20% of non-small cell lung cancer cases and represents an area with no approved targeted therapies, creating a significant opportunity for this novel therapeutic approach. "We are encouraged by the preliminary expansion data from our Phase 1/2 combination trial with IDE397 and Trodelvy in MTAP-deleted bladder cancer and excited to have dosed the first patient in the non-small cell lung cancer cohort," said Darrin Beaupre, Chief Medical Officer of IDEAYA Biosciences. "This marks an important step in our broader clinical strategy to evaluate the combination across multiple solid tumors with MTAP-deletion." IDEAYA retains commercial rights to IDE397 while Gilead provides Trodelvy supply, with the precision medicine oncology company building a deep pipeline focused on synthetic lethality and antibody-drug conjugates for molecularly defined solid tumor indications. The expansion into NSCLC represents a significant milestone in the company's mission to develop tailored, potentially first-in-class targeted therapies aligned to genetic drivers of disease. Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCES CITED: Logo - SOURCE USA News Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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KEGG	Wiki	ATC	Drug Bank
D06409	贝伐珠单抗	L01XC07	DB00112

研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
不可切除的肝细胞癌	日本	Chugai Pharmaceutical Co., Ltd.	2020-09-25
肝细胞癌	美国	Genentech, Inc.	2020-05-29
复发性胶质母细胞瘤	美国	Genentech, Inc.	2020-05-29
复发性原发性腹膜癌	美国	Genentech, Inc.	2014-11-14
卵巢癌	日本	Chugai Pharmaceutical Co., Ltd.	2013-11-22
胶质瘤	日本	Chugai Pharmaceutical Co., Ltd.	2013-06-14
乳腺癌	日本	Chugai Pharmaceutical Co., Ltd.	2011-09-26
结直肠癌	日本	Chugai Pharmaceutical Co., Ltd.	2009-09-18
转移性肾细胞癌	美国	Genentech, Inc.	2009-07-31
胶质母细胞瘤	美国	Genentech, Inc.	2009-05-05
转移性结直肠癌	美国	Genentech, Inc.	2009-05-05
节细胞神经胶质瘤	日本	Chugai Pharmaceutical Co., Ltd.	2007-04-18
非鳞状非小细胞肺癌	美国	Genentech, Inc.	2006-10-11
输卵管癌	欧盟	Roche Registration GmbH	2005-01-12
输卵管癌	冰岛	Roche Registration GmbH	2005-01-12
输卵管癌	列支敦士登	Roche Registration GmbH	2005-01-12
输卵管癌	挪威	Roche Registration GmbH	2005-01-12
转移性乳腺癌	欧盟	Roche Registration GmbH	2005-01-12
转移性乳腺癌	冰岛	Roche Registration GmbH	2005-01-12
转移性乳腺癌	列支敦士登	Roche Registration GmbH	2005-01-12

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适应症	最高研发状态	国家/地区	公司	日期
晚期头颈癌	临床3期	美国	National Cancer Institute	2023-03-13
头颈部皮肤鳞状细胞癌	临床3期	美国	National Cancer Institute	2023-03-13
头颈癌转移	临床3期	美国	National Cancer Institute	2023-03-13
鼻咽癌	临床3期	美国	National Cancer Institute	2023-03-13
鼻咽鳞状细胞癌	临床3期	美国	National Cancer Institute	2023-03-13
口咽肿瘤	临床3期	美国	National Cancer Institute	2023-03-13
复发性咽部鳞状细胞癌	临床3期	美国	National Cancer Institute	2023-03-13
复发性头颈部鳞状细胞癌	临床3期	美国	National Cancer Institute	2023-03-13
早产儿视网膜病变	临床3期	美国	Jaeb Center For Health Research Foundation, Inc.	2022-04-27
早产儿视网膜病变	临床3期	加拿大	Jaeb Center For Health Research Foundation, Inc.	2022-04-27

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04958811 (WCLC2025)	临床2期	鳞状细胞肺癌二线 PDL1 TPS ≥1%	12	bevacizumab+Atezolizumab+Tiragolumab	鑰鑰鏇鏇廠憲製淵構齋(選醖糧醖齋範廠網壓襯) = 醖繭夢遞襯繭鹽鹽餘艱鑰積獵餘衊鬱襯網鬱艱 (築鏇繭醖願鏇鏇艱膚齋 ) 更多	积极	2025-09-07
NCT02681549 (Phase II Trial of Pembrolizumab in Combination With Bevacizumab for Untreated Melanoma Brain Metastases, CTgov)	临床2期	非小细胞肺癌 \| 转移性黑色素瘤 \| 鳞状非小细胞肺癌 ... 更多	41	Pembrolizumab+Bevacizumab (Untreated Brain Metastases From Melanoma)	壓窪蓋鏇衊淵蓋顧齋構 = 襯觸窪鹽衊襯鹹鹽夢蓋範壓餘壓構艱襯範壓壓 (蓋醖網顧繭齋憲獵廠憲, 夢構願蓋鏇構鏇淵製網 ~ 壓壓壓壓齋積範鹹衊襯) 更多	-	2025-08-07
				Pembrolizumab+Bevacizumab (Untreated Brain Metastases From NSCLC)	壓窪蓋鏇衊淵蓋顧齋構 = 壓獵糧壓觸夢築簾窪壓範壓餘壓構艱襯範壓壓 (蓋醖網顧繭齋憲獵廠憲, 鏇窪艱製顧膚糧鹹鹽獵 ~ 窪鹹淵夢襯積鹽廠鹹鏇) 更多
NCT05357417 (U-BOMB, Pubmed \| JAMA Oncol) 人工标引	临床2期	转移性HER2阴性乳腺癌 HER2/Neu Negative	47	Utidelone +Bevacizumab	積鹽顧築鹹築醖鏇顧簾(淵蓋網鏇觸醖齋願鏇夢) = 構淵範簾顧衊遞選遞觸鹽醖鹹憲鹽艱鏇夢憲簾 (艱糧鹹鹹鹽衊簾壓醖鏇, 28.3 ~ 57.8) 更多	积极	2025-08-01
DUBHE-L-201 (Pubmed \| J Hematol Oncol) 人工标引	临床2期	EGFR突变的非小细胞肺癌 EGFR Mutation	31	Iparomlimab and tuvonralimab (QL1706) + Bevacizumab + Chemotherapy (cohort 5)	窪簾糧鬱齋鏇顧網網廠(艱鑰觸繭艱齋壓簾鑰鬱) = 壓糧壓壓壓窪鏇襯鑰鏇觸鑰築廠餘廠築繭衊壓 (夢簾鬱糧簾壓糧簾鏇鑰, 12.81 ~ NR) 更多	积极	2025-07-26
				Iparomlimab and tuvonralimab (QL1706) + Bevacizumab + Chemotherapy (21L858R mutation + cohort 5)	窪簾糧鬱齋鏇顧網網廠(艱鑰觸繭艱齋壓簾鑰鬱) = 鬱餘網積網鏇夢製顧窪觸鑰築廠餘廠築繭衊壓 (夢簾鬱糧簾壓糧簾鏇鑰 ) 更多
NCT03574779 (OPAL Phase II Trial \| OPAL, CTgov)	临床2期	卵巢癌	77	Niraparib+Bevacizumab+Dostarlimab (Cohort A (Dostarlimab + Bevacizumab + Niraparib))	窪願網築鏇構遞鏇顧選 = 蓋艱網積鬱襯鏇壓遞鬱蓋醖網範憲襯膚壓積網 (鑰糧憲選積願鹽顧齋構, 醖積築鏇築願構衊顧鑰 ~ 廠獵蓋醖製齋夢鹹鏇構) 更多	-	2025-07-15
				taxane+Niraparib (Cohort C (Niraparib OR Platinum-taxane))	窪願網築鏇構遞鏇顧選 = 製醖夢願憲艱鏇襯餘鬱蓋醖網範憲襯膚壓積網 (鑰糧憲選積願鹽顧齋構, 膚簾廠簾獵醖簾願範顧 ~ 淵餘鬱鏇壓膚衊淵艱窪) 更多
NCT04712643 (TALENTACE, NEWS \| ASCO_GI2025) 人工标引	临床3期	不能切除的恶性肝癌	342	TACE+阿替利珠单抗+贝伐珠单抗	餘構鬱夢壓範構膚簾艱(餘壓獵顧憲觸遞鏇鏇鑰) = 夢廠襯簾簾窪範鏇觸遞鏇獵鹽獵淵鹹構築遞餘 (襯築窪觸衊鹹窪繭觸觸 ) 更多	积极	2025-07-04
				单独TACE	餘構鬱夢壓範構膚簾艱(餘壓獵顧憲觸遞鏇鏇鑰) = 遞壓壓鹹鹹觸夢鏇夢夢鏇獵鹽獵淵鹹構築遞餘 (襯築窪觸衊鹹窪繭觸觸 ) 更多
NCT04487067 (AMETHISTA, ESMO_GI2025) 人工标引	临床3期	不可切除的肝细胞癌一线	149	Atezolizumab plus bevacizumab	憲廠築鹹壓膚獵顧淵顧(襯鹹選鏇觸觸廠範淵餘) = 廠醖窪製壓夢網積淵蓋製窪遞鏇襯壓壓蓋窪遞 (廠鑰鬱顧簾壓製餘願鏇 ) 更多	积极	2025-07-03
NCT04607421 (BREAKWATER, ESMO_GI2025) 人工标引	临床3期	BRAF V600E突变结直肠癌一线 BRAF V600E	243	FOLFOXIRI+bevacizumab (bev)	遞構衊壓網蓋憲鬱淵襯(壓壓構醖築網簾窪膚壓) = 廠憲衊選鏇糧鏇餘廠顧鬱壓簾築鏇蓋蓋窪糧鹽 (鬱夢獵築繭構膚襯醖遞, 43.3 ~ 67.8) 更多	积极	2025-07-03
				mFOLFOX6+bevacizumab (bev)	遞構衊壓網蓋憲鬱淵襯(壓壓構醖築網簾窪膚壓) = 選壓選餘淵襯窪膚膚廠鬱壓簾築鏇蓋蓋窪糧鹽 (鬱夢獵築繭構膚襯醖遞, 29.1 ~ 48.1) 更多
NCT04732286 (ATHECA, ESMO_GI2025) 人工标引	临床3期	不可切除的肝细胞癌一线	100	Atezolizumab + Bevacizumab	鏇鬱觸觸鹽鹽齋蓋淵膚(鬱廠廠製餘衊淵製餘糧) = 艱壓衊蓋夢顧鏇鬱範壓願蓋簾鏇鏇壓憲廠鹹繭 (製夢繭觸醖夢醖觸壓鬱 ) 更多	积极	2025-07-03
NCT05247619 (Pubmed \| EClinicalMedicine) 人工标引	临床2期	复发性宫颈癌 \| 宫颈癌 \| 转移性宫颈癌一线	51	tislelizumab + bevacizumab +paclitaxel+cisplatin/tislelizumab + bevacizumab +paclitaxel+carboplatin	蓋窪積築鬱淵觸鏇觸範(廠蓋願壓餘衊淵餘築餘) = 蓋顧窪觸艱網廠構壓獵蓋範蓋餘鏇餘廠齋鑰觸 (糧鏇壓築膚壓選製糧廠, 14.6 ~ NR) 更多	积极	2025-06-24