Phase II randomized trail of Gemcitabine and Irinotecan in Patients with Platinum Refractory and Resistant Mullerian carcinoma (tailored dose vs optimal dose chemotherapy)

开始日期2046-12-31

申办/合作机构-

NCT06592664

/ Withdrawn临床1/2期

A Phase 1b/2a, Double-blind, Placebo-controlled, Three Arm, Randomized Study Evaluating a Single Intravenous Push Followed by a Continuous Infusion of Certepetide Over 4 Hours When Added to Standard of Care (SoC) Versus Two Intravenous Pushes of Certepetide When Added to SoC, Versus SoC Alone in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (FORTIFIDE)

The goal of this clinical trial is to test a new drug plus standard treatment compared with standard treatment alone in people with metastatic pancreatic ductal adenocarcinoma.
The main questions it aims to answer are:
* is the new drug plus standard treatment safe and tolerable
* is the new drug plus standard treatment more effective than standard treatment
Participants will:
* Visit the clinic three times every 28 days for treatment and tests
* Have CT or MRI scans every 8 weeks while on treatment

开始日期2030-01-01

申办/合作机构

Lisata Therapeutics, Inc.

NCT07639528

/ Not yet recruiting临床2期IIT

Phase II, Open Label, Non-Randomized, Study of Optimal Preoperative Therapy for Intrahepatic Cholangiocarcinoma (OPTIC)

This phase II trial tests the safety and effectiveness of preoperative immunotherapy with durvalumab and chemotherapy with cisplatin and gemcitabine with or without futibatinib targeted therapy in treating patients with intrahepatic cholangiocarcinoma that can be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving immunotherapy with durvalumab and chemotherapy with cisplatin and gemcitabine and/or targeted therapy with futibatinib before surgery may make the tumor smaller for resection and may help prevent the cancer from coming back. Patients whose molecular profiling test result show a genetic change called FGFR2 fusion, rearrangement, or activating mutation, receive immunotherapy, chemotherapy and targeted therapy while patients without a FGFR2 fusion, rearrangement, or activating mutation just receive immunotherapy and chemotherapy. Giving targeted therapy based on molecular profile test results prior to attempted resection for patients with intrahepatic cholangiocarcinoma that has a risk for either not being able to be removed or for coming back after it has been removed may help improve treatment outcomes in patients with resectable intrahepatic cholangiocarcinoma.

开始日期2027-12-10

申办/合作机构

Northwestern University

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100 项与盐酸吉西他滨相关的转化医学

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100 项与盐酸吉西他滨相关的专利（医药）

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15,617

项与盐酸吉西他滨相关的文献（医药）

2026-08-01·UROLOGIC CLINICS OF NORTH AMERICA

Emerging Intravesical Therapies for Non–Muscle-Invasive Bladder Cancer

Review

作者: Bukavina, Laura ; Isali, Ilaha ; Wang, Betty ; Calaway, Adam

Non-Muscle-Invasive Bladder Cancer poses significant therapeutic challenges due to high recurrence and progression rates. While intravesical Bacillus Calmette-Guérin (BCG) has long been the standard, limitations in efficacy, global shortages, and patient-specific contraindications to radical cystectomy have fueled the development of novel bladder-sparing therapies. Recent advances include UGN-102 for low-grade/intermediate-risk disease and multiple FDA-approved agents-nadofaragene firadenovec, TAR-200, and nogapendekin alfa inbakicept-for BCG-unresponsive disease. Ongoing trials of TAR-210, cretostimogene, and other combination regimens promise to further expand options. Comparative studies and real-world evidence will be critical to define optimal sequencing, benchmark outcomes against radical cystectomy, and address quality-of-life considerations.

2026-06-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Advances in intravesical therapy for non-muscle-invasive bladder cancer

Review

作者: Tang, Yanfeng ; Zeng, Hao ; Zhu, Qiyu ; Xu, Chenhao ; Chen, Junru ; Liu, Haoyang ; Wang, Ling

Non-muscle-invasive bladder cancer (NMIBC) accounts for roughly 75% of newly diagnosed bladder cancer and associates with high risk of recurrence and progression. Intravesical therapy remains the cornerstone of NMIBC management following transurethral resection of bladder tumor (TURBT). For low-risk NMIBC, immediate single instillation of chemotherapy after TURBT effectively reduces recurrence. Intermediate-risk patients could benefit from either intravesical chemotherapy or Bacillus Calmette-Guérin (BCG) instillation, with emerging therapies such as UGN-102 chemoablation showing promise. For high/very high-risk NMIBC, full-dose, 3-year BCG instillation remains the standard of care, However, global BCG shortages and treatment failures have prompted the need for alternative strategies. Optimization of BCG regimens, such as two induction courses, may preserve efficacy while improving feasibility. Moreover, alternative agents such as sequential gemcitabine and docetaxel instillation have demonstrated favorable outcomes in both BCG-naïve and BCG-unresponsive patients. For those with BCG failure, a number of novel therapies are under active investigation. Gene therapy (nadofaragene firadenovec), oncolytic viral therapy (CG0070), interleukin-15 superagonist (Nogapendekin alfa-inbakicept), and innovative drug delivery systems (TAR-200) have shown encouraging clinical potential in this population. This review provides an overview of current intravesical treatment strategies for NMIBC across different risk groups and highlights promising new approaches aimed at overcoming the limitations of BCG therapy.

2026-05-04·Expert Opinion On Drug Safety

Potential drugs for reducing the occurrence of immune checkpoint inhibitor-induced interstitial lung disease: an exploratory study using the JADER and FAERS databases

Article

作者: Koseki, Takenao ; Kondo, Masashi ; Hatano, Masakazu ; Utsunomiya, Ayaka ; Yamada, Shigeki ; Imaizumi, Kazuyoshi

BACKGROUND:

Immune checkpoint inhibitors (ICIs) play a central role in cancer immunotherapy. However, the occurrence of immune-related adverse events, especially ICI-induced interstitial lung disease (ICI-ILD), is life-threatening and affects the effectiveness of ICI treatment. This study aimed to explore potential drugs to mitigate ICI-ILD occurrence using data from the Japanese Adverse Drug Event Report (JADER) and the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS [JAPIC AERS]).

RESEARCH DESIGN AND METHODS:

We investigated concomitant drugs that reduce ILD associated with four ICIs - nivolumab, pembrolizumab, atezolizumab, and durvalumab - across the JADER and FAERS databases. Subsequently, the identified common concomitant drugs that reduce the occurrence of ICI-ILD were detected and analyzed.

RESULTS:

We found omega-3 fatty acids, loperamide, and amlodipine as common concomitant drugs that reduced ICI-ILD occurrence in both the JADER and FAERS databases. Omega-3 fatty acids reportedly have many effects in animal models of drug-induced ILD, including their association with ILD in humans and anti-inflammatory effects against ICI-ILD. However, loperamide and amlodipine reportedly have minimal effects against ILD, thereby necessitating further evaluation.

CONCLUSION:

Omega-3 fatty acids have emerged as potential agents for reducing ICI-ILD occurrence, as evidenced by findings from two different pharmacovigilance databases.

1,545

项与盐酸吉西他滨相关的新闻（医药）

2026-07-14

·BioSpace

Can-Fite Secures Australian Patent Allowance Supporting Namodenoson Development and Marketing in Liver and Pancreatic Cancer

Ramat Gan, Israel, July 14, 2026 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, today announced that the Australian Patent Office has allowed Patent Application No. 2021290439 entitled "Treatment of Advanced Metastatic Cancer." The patent complements Can-Fite's rapidly advancing oncology pipeline. Namodenoson is currently being evaluated in a pivotal Phase 3 study for advanced hepatocellular carcinoma following FDA and EMA protocol agreement. In pancreatic cancer, the Company recently completed a Phase 2a clinical study demonstrating an excellent safety pro with encouraging survival outcomes and durable disease stabilization and is planning a Phase 2b study evaluating Namodenoson in combination with gemcitabine. "This patent allowance further strengthens our global intellectual property portfolio surrounding Namodenoson and reinforces the long-term value of our oncology franchise," said Pnina Fishman, Ph.D., Chairperson and Chief Scientific Officer of Can-Fite BioPharma. "Importantly, the patent supports two of our most advanced oncology programs—hepatocellular carcinoma and pancreatic cancer—and extends protection for our innovative therapeutic approach in a major international market." Namodenoson selectively targets the A3 adenosine receptor (A3AR), which is highly expressed in inflammatory and cancer cells. Activation of A3AR has been shown to induce apoptosis of tumor cells while sparing normal tissues, contributing to the compound's favorable safety pro across clinical studies. About Namodenoson Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is currently being evaluated in a pivotal Phase 3 trial for advanced liver cancer, concluded successfully a Phase 2a study in pancreatic cancer and enroll patients for a Phase 2b trial for the treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential expression may be one of the important factors that accounts for the excellent safety of the drug. About Can-Fite BioPharma Ltd. Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company’s lead drug candidate, Piclidenoson recently reported topline results in a Phase 3 trial for psoriasis and commenced a pivotal Phase 3 trial. Can-Fite’s liver drug, Namodenoson, is being evaluated in a Phase III trial for hepatocellular carcinoma (HCC), a Phase 2b trial for the treatment of MASH, and in a Phase 2a study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety pro experience in over 1,600 patients in clinical studies to date. For more information please visit: . Forward-Looking Statements This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, the Company’s plans to conduct a Phase 2b study evaluating Namodenoson in combination with gemcitabine. All statements in this communication, other than those relating to historical facts, are “forward looking statements”. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause Can-Fite’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among other things, our market and other conditions, history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; risks related to not satisfying the continued listing requirements of NYSE American; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time to time in the “Risk Factors” section of Can-Fite’s Annual Report on Form 20-F filed with the SEC on March 26, 2026 and other public reports filed with the SEC and in its periodic filings with the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. Contact Can-Fite BioPharma Motti Farbstein info@canfite.com +972-3-9241114

临床2期孤儿药临床结果临床3期快速通道

2026-07-11

·BioSpace

Amplia Announces Publication of New FAK Inhibitor Patent Application

New patent application published covering chemically novel FAK inhibitors discovered by Amplia Application expands Amplia’s intellectual property portfolio supporting its FAK inhibitor program If granted, patent protection for the new molecules and their use would extend to 2046 New compounds broaden pipeline optionality and may support future development and partnering opportunities July 09, 2026 -- Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), (“Amplia” or the “Company”), is pleased to announce publication of a new patent application describing chemically novel inhibitors of focal adhesion kinase (FAK) discovered by the Company. The patent application further expands Amplia’s FAK intellectual property portfolio and, if granted, would provide protection for the novel molecules described, and their use, out to 2046. Amplia’s patent portfolio covers its lead drug narmafotinib, currently in clinical trials for pancreatic and ovarian cancer, and a second drug candidate (AMP886) being investigated in preclinical studies. The new patent application describes additional chemical compounds closely related to narmafotinib that also demonstrate potent and selective activity against FAK. These molecules broaden Amplia’s development pipeline and may provide future opportunities for evaluation across additional indications. Importantly, the patent application adds depth to the Company’s existing intellectual property estate around its FAK inhibitor program and supports the long-term commercial value of its development assets. Dr. Chris Burns, CEO and Managing Director of Amplia, commented, “This patent application further strengthens our portfolio of potent FAK inhibitors and highlights the depth of innovation being generated by the Company. In addition to supporting narmafotinib, it creates future development and partnering optionality through a broader suite of novel molecules targeting this important pathway.” Amplia Therapeutics Limited is an Australian pharmaceutical company advancing a pipeline of Focal Adhesion Kinase (FAK) inhibitors for cancer and fibrosis. FAK is an increasingly important target in the field of cancer and Amplia has a particular development focus in fibrotic cancers such as pancreatic and ovarian cancer. FAK also plays a significant role in a number of chronic diseases, such as idiopathic pulmonary fibrosis (IPF). Narmafotinib (AMP945) is the company’s best-in-class inhibitor of the protein FAK, a protein over-expressed in pancreatic cancer and a drug target gaining increasing attention for its role in solid tumours. The drug, which is a highly potent and selective inhibitor of FAK, has shown promising data in a range of preclinical cancer studies. Narmafotinib is currently undergoing a clinical trial (the ACCENT trial) where it is dosed in combination with the chemotherapies gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer. The trial has achieved its desired outcome in achieving a response rate of 36%, including 5 Complete Responses and a pathological Complete Response, across 64 patients. A second trial – AMPLICITY – is being run at sites in Australia investigating the combination of narmafotinib with the chemotherapy FOLFIRINOX in advanced pancreatic cancer patients. The content above comes from the network. if any infringement, please contact us to modify.

临床结果

2026-07-10

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王风华教授：消化道肿瘤治疗进入「精准破局」时代，前沿进展加速转化为患者获益

6 月 26 日至 27 日，2026 年中国肿瘤内科大会（CSMO）暨抗肿瘤新药发展大会在广州举行。作为聚焦肿瘤内科诊疗突破、新药研发动态及基础与转化前沿进展的重要学术平台，本届大会汇聚肿瘤学领域多项研究进展。近年来，以胃癌、肝癌和胆道癌等为代表的高发消化道肿瘤，正在从传统治疗模式逐步迈向精准免疫、靶向治疗、抗体偶联药物（ADC）和多模式联合并行发展的新阶段。随着新靶点不断被发现、新型药物持续开发、关键临床研究数据陆续公布，消化道肿瘤治疗正呈现出更加精准化、分层化和个体化的趋势。值此之际，丁香园肿瘤时间特邀中山大学肿瘤防治中心王风华教授，结合胃癌、肝癌和胆道癌等消化道肿瘤中的关键研究进展，围绕新靶点开发、新型药物迭代、免疫联合及多模式综合治疗等方向进行系统解读，探讨前沿研究如何从大会数据和指南推荐走向临床实践，并最终转化为患者可及的治疗获益。胃癌精准治疗拓展：从分子分型到新靶点新药物晚期胃癌是消化道肿瘤精准治疗进展较为集中的领域之一。随着 HER2、MSI/MMR、PD-L1 和 CLDN18.2 等分子标志物逐步进入临床决策，胃癌治疗正在从传统分期治疗转向分子分型指导下的精准治疗[1]。在此基础上，HER2 和 CLDN18.2 构成了当前胃癌靶向治疗中证据较为充分的代表性方向，而 MET 扩增等更细分分子亚型的探索，也进一步拓展了胃癌精准治疗的边界。 HER2 是胃癌靶向治疗中最早实现临床突破的靶点之一。ToGA 研究证实抗 HER2 单抗曲妥珠单抗联合化疗可改善 HER2 阳性晚期胃癌患者生存，也由此开启了胃癌抗 HER2 治疗时代[2]。近年来，HER2 靶向治疗进一步向免疫联合和双抗策略拓展。一线治疗中，KEYNOTE-811 研究确立了抗 HER2 治疗联合免疫治疗的临床价值[3]；HERIZON-GEA-01 研究也提示，HER2 双抗联合免疫和化疗可进一步改善 PFS，mPFS 为 12.4 个月 vs 8.1 个月，同时联合免疫和化疗方案 mOS 达 26.4 个月，提示 HER2 双抗联合方案仍具有进一步提升疗效的潜力。在二线治疗中，HER2 ADC 和 HER2 双抗正在不断丰富治疗选择[4]。DESTINY-Gastric04 显示，HER2 ADC 德曲妥珠单抗较雷莫西尤单抗联合紫杉醇显著延长 HER2 阳性患者 OS，mOS 为 14.7 个月 vs 11.4 个月，2 年 OS 率实现翻倍（29.0% vs 13.9%），整体安全性可控[5]。KC-WISE 研究提示，曲妥珠单抗治疗后进展患者仍可从 HER2 双抗 KN026 联合化疗中获益[6]。此外，围绕 HER2 高表达、中低表达及免疫联合、ADC 和双抗等方向，多项 III 期研究仍在推进，显示胃癌 HER2 治疗正走向更精细的分层和组合策略。 CLDN18.2 则为晚期胃癌打开了另一条精准治疗路径。SPOTLIGHT 和 GLOW 两项 III 期研究显示，CLDN18.2 单抗联合化疗在 CLDN18.2 阳性晚期胃癌中可较单纯化疗改善 PFS 和 OS，共同确证了 CLDN18.2 作为治疗靶点的临床价值，推动晚期胃癌精准治疗边界的拓展[7, 8]。在单抗验证靶点价值后，CLDN18.2 药物开发进一步向 ADC 等新形式延伸。Sone-Ve（AZD0901）作为 CLDN18.2 ADC，正在二线及以上晚期胃癌中推进全球 III 期 CLARITY-Gastric01 研究[9]。与此同时，CLARITY-PanTumor01 子研究数据显示，Sone-Ve 二线及以上单药治疗 CLDN18.2 阳性胃癌的客观缓解率（ORR）为 28.4%，mPFS 为 4.2 个月[10]，提示 CLDN18.2 ADC 在经治患者中已显示出可观察的抗肿瘤活性。可以看到，CLDN18.2 靶向治疗的发展已不止于单抗对靶点价值的验证，而是进一步延伸至以 ADC 为代表的新型药物平台。随着 Sone-Ve 等 CLDN18.2 ADC 进入关键临床研究阶段，多项 III 期研究仍在推进，提示这一靶点正在从单一药物突破，走向多药物、多线别的系统布局。在 HER2 和 CLDN18.2 之外，MET 扩增进一步体现了胃癌精准治疗向更细分分子亚型延伸的趋势。赛沃替尼注册 II 期研究中，MET 扩增的晚期胃癌关键期人群 ORR 为 32.3%，mPFS 为 4.0 个月，mOS 为 6.9 月，提示 MET 抑制剂有望为既往治疗选择有限的 MET 扩增患者提供新的治疗机会[11]。此外，围绕 MET 扩增/过表达及不同检测标准的多项研究仍在推进，也说明这一方向未来的关键不只是药物开发，更关键的是进一步精准界定获益人群及检测阈值。从 HER2、CLDN18.2 到 MET，晚期胃癌精准治疗的核心已不只是发现更多靶点，而是如何把不同分子特征转化为可执行的治疗选择。对于缺乏常规靶点或标准治疗失败的患者，可进一步借助二代测序寻找潜在治疗靶点，为治疗提供更多探索空间[1]。由分子分型出发，延伸至药物选择、疗效评估和后续治疗调整，正是胃癌精准治疗不断向前拓展的重要体现。肝癌策略演进：双免与多模式联合持续推进肝癌治疗的前沿进展，正在沿着系统治疗升级和局部联合探索两条路径推进。晚期肝癌系统治疗从靶向药物起步，逐步拓展至免疫单药、靶免联合和双免策略，中期肝癌则围绕 TACE 联合系统治疗，探索更深缓解和更长疾病控制的可能。在这一背景下，双免长期获益与 TACE 联合系统治疗，构成了当前肝癌治疗进展的两条重要主线。 HIMALAYA 研究验证了双免策略在不可切除肝癌中的长期价值。单次 CTLA-4 抑制剂曲美木单抗联合 PD-L1 抑制剂度伐利尤单抗的 STRIDE 方案较索拉非尼改善 OS，mOS 为 16.43 个月 vs 13.77 个月。长期随访中，STRIDE 组 5 年 OS 率较索拉非尼几乎翻倍[12]。该结果提示，双免治疗的意义不只在于短期控瘤，更在于通过免疫协同带来更持久的生存获益。SINOVA 研究也进一步补充了双免策略的证据，其一线治疗晚期肝细胞癌的探索显示，双免联合方案较对照治疗带来 OS 改善，mOS 为 44.0 个月 vs 22.9 个月，为双免路径提供了新的临床证据[13]。在系统治疗升级之外，TACE 联合系统治疗正在成为中期肝癌的重要探索方向。从已有 III 期研究看，EMERALD-1、LEAP-012、TALENTACE、EMERALD-3 和 SHR-1210-336 均围绕 TACE 联合系统治疗展开，并从 mPFS、OS 和 ORR 等维度呈现出不同程度的获益信号；其中，mPFS 获益较为明确。以 EMERALD-1 为例，以度伐利尤单抗为基础的 TACE 联合系统治疗将 mPFS 由 8.2 个月延长至 15.0 个月。2026 ASCO 公布的 EMERALD-3 和 SHR-1210-336 数据也也从不同联合方案角度，进一步支持 TACE 联合系统治疗改善疾病控制的探索方向[14-18]。上述结果共同提示，在系统治疗中加入 TACE 后，有助于在局部控瘤基础上进一步延缓疾病进展。从 OS 维度看，五项 III 期研究均提供了生存获益相关观察，但不同研究在方案组成、随访时间和后续治疗影响上存在差异，因此 OS 结果的成熟度和表现并不完全一致[14-18]。整体来看，部分研究已显示出 OS 获益趋势，提示 TACE 联合系统治疗的价值可能不止于延缓进展，还会影响长期获益走向。ORR 的提升则进一步说明，TACE 联合系统治疗的价值不只在于延缓进展，也在于提高肿瘤缓解深度。五项 III 期研究中，联合治疗组 ORR 较对照组均有提升，增幅多集中在约 13%–15%[14-18]，说明系统治疗的加入不仅可能延长疾病控制时间，也有助于提高肿瘤缩小和深度缓解的机会。对于中期肝癌而言，更高的 ORR 意味着更强的局部控制和潜在转化可能，也提示免疫治疗可能是推动缓解加深的重要因素之一。肝癌治疗正在从单一系统治疗选择，走向系统治疗升级与局部联合探索并行推进。双免策略强调长期生存获益，TACE 联合系统治疗则通过 mPFS、OS 及 ORR 等多维度证据，进一步显示出延缓进展、加深缓解和争取转化机会的潜力。未来，如何根据疾病阶段、肿瘤负荷和患者状态选择合适组合，将成为推动肝癌患者长期获益的关键。胆道癌治疗推进：从化免联合到多策略探索晚期胆道癌过去长期依赖吉西他滨联合铂类化疗，治疗选择相对有限，生存获益提升缓慢。随着免疫检查点抑制剂进入一线治疗，胆道癌治疗开始从单纯化疗向化疗联合免疫转变[19]。 TOPAZ-1、KEYNOTE-966 两项全球 III 期研究共同奠定了晚期胆道癌一线化免联合治疗的证据基础，均显示在标准化疗基础上联合 PD-1/PD-L1 抑制剂可带来 OS 获益。其中，TOPAZ-1 研究显示，度伐利尤单抗联合化疗不仅改善 mOS，也在 mPFS 和 ORR 上展示出获益：mPFS 由 5.7 个月提升至 7.2 个月，ORR 由 18.7%提高至 26.7%。长期随访中，36 月和 48 月 OS 率分别达到 14.6% 和 11.8%，均较对照组保持优势，提示部分患者可能获得更持久生存[20]。KEYNOTE-966 进一步验证了化免联合的 OS 获益，免疫联合化疗将 mOS 由 10.9 个月延长至 12.7 个月[21]。KN035-CN-005 则提供了中国患者皮下 PD-L1 抑制剂联合化疗的研究证据，同样显示 OS 改善[22]。从全球 III 期研究到中国患者数据，化免联合正在不断夯实其在晚期胆道癌一线治疗中的地位，也为后续不同给药方式和不同人群中的治疗优化提供了更多依据。在一线化免联合之外，胆道癌治疗也正在向分子分型指导下的精准治疗延伸。FGFR2 融合/重排、IDH1 突变、HER2 扩增 / 过表达、BRAF V600E、NTRK 融合、MSI-H/dMMR 等分子特征，为部分患者提供了靶向治疗或免疫治疗的进一步选择[19]。由此，胆道癌治疗正在形成一线化免奠定基础、分子检测筛选人群、后线靶向延伸获益的多策略路径，也推动胆道癌治疗从以化疗为主的经验性模式，逐步迈向更加精准、个体化的治疗阶段。小结消化道肿瘤治疗正从单一药物突破迈向精准诊疗、多模式联合和全程管理并行发展的新阶段。胃癌不断拓展 HER2、CLDN18.2、MET 等靶点的精准治疗边界；肝癌围绕双免治疗和 TACE 联合系统治疗持续优化长期获益与转化机会；胆道癌则在化免联合奠定一线治疗基础的同时，逐步向分子分型指导下的精准治疗延伸。不同瘤种的发展路径虽各有侧重，但共同体现出更加精准的人群筛选、更合理的治疗组合和更加个体化的临床决策。与此同时，前沿研究的真正价值不仅在于数据更新，更在于能够转化为患者可及的治疗获益。这既需要新药和新策略不断涌现，也依赖规范的分子检测、精准的患者筛选以及真实世界证据的持续积累。未来，随着精准诊断、精准治疗和精准疗效评估不断完善，消化道肿瘤诊疗将进一步实现从研究突破到临床实践的高质量转化，最终帮助更多患者获得更长生存和更高生活质量。王风华教授医学博士，博士生导师中山大学肿瘤防治中心肿瘤内科主任医师中国抗癌协会肿瘤靶向治疗专业委员会副主委中国抗癌协会肿瘤支持专业委员会副主委中国临床肿瘤协会胃癌专家委员会副主委中国抗癌协会肿瘤临床化疗专业委员会委员中国临床肿瘤协会胰腺癌专家委员会委员中国老年医学学会肿瘤学分会常委中华医学会肿瘤学分会胰腺肿瘤学组委员广东省抗癌协会肿瘤靶向治疗专业委员会主委广东省抗癌协会胰腺癌专业委员会副主委广东省健康管理学会肿瘤防治专业委员会副主委广东省抗癌协会癌症康复与姑息治疗专委会常委广东省女医师协会消化肿瘤专业委员会副主委 ✩ 本文仅供医疗卫生等专业人士参考内容策划：Kiki 项目审核：于轩参考文献： [1]Yu, J. and R. Mehta, Biomarker-Driven Approach to the Treatment of Metastatic Gastric or Gastroesophageal Adenocarcinoma. J Natl Compr Canc Netw, 2025. 23(5). [2]Bang, Y.J., et al., Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet, 2010. 376(9742): p. 687-97. [3]Janjigian, Y.Y., et al., Pembrolizumab in HER2-Positive Gastric Cancer. N Engl J Med, 2024. 391(14): p. 1360-1362. [4]Elimova, E., et al., Zanidatamab + chemotherapy (CT) ± tislelizumab for first-line (1L) HER2-positive (HER2+) locally advanced, unresectable, or metastatic gastroesophageal adenocarcinoma (mGEA): Primary analysis from HERIZON-GEA-01. Journal of Clinical Oncology, 2026. 44(2_suppl): p. LBA285-LBA285. [5]Shitara, K., et al., Trastuzumab Deruxtecan or Ramucirumab plus Paclitaxel in Gastric Cancer. N Engl J Med, 2025. 393(4): p. 336-348. [6]Liu, R., et al., Anbenitamab in previously treated HER2-positive gastric cancer (KC-WISE): prespecified interim analysis of a randomized, phase III clinical trial. Annals of Oncology, 2026. 37(6): p. 777-786. [7]Shitara, K., et al., Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial. Lancet, 2023. 401(10389): p. 1655-1668. [8]Shah, M.A., et al., Zolbetuximab plus CAPOX in CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: the randomized, phase 3 GLOW trial. Nat Med, 2023. 29(8): p. 2133-2141. [9]Janjigian, Y.Y., et al., CLARITY-Gastric 01: A randomized phase 3 study of AZD0901, a Claudin18.2 (CLDN18.2)-targeted antibody-drug conjugate, in second- or later-line (2L+) advanced gastric or gastroesophageal junction cancer (GC/GEJC). Journal of Clinical Oncology, 2025. 43(4_suppl): p. TPS507-TPS507. [12]Rimassa, L., et al., Five-year overall survival update from the HIMALAYA study of tremelimumab plus durvalumab in unresectable HCC. J Hepatol, 2025. 83(4): p. 899-908. [14]Sangro, B., et al., Durvalumab with or without bevacizumab with transarterial chemoembolisation in hepatocellular carcinoma (EMERALD-1): a multiregional, randomised, double-blind, placebo-controlled, phase 3 study. Lancet, 2025. 405(10474): p. 216-232. [15]Kudo, M., et al., Transarterial chemoembolisation combined with lenvatinib plus pembrolizumab versus dual placebo for unresectable, non-metastatic hepatocellular carcinoma (LEAP-012): a multicentre, randomised, double-blind, phase 3 study. Lancet, 2025. 405(10474): p. 203-215. [16] Dong, J., et al., LBA2 TALENTACE: A phase III, open-label, randomized study of on-demand transarterial chemoembolization (TACE) combined with atezolizumab + bevacizumab (Atezo+Bev) or on-demand TACE alone in patients with systemically untreated, intermediate-to-high burden unresectable hepatocellular carcinoma (uHCC). Annals of Oncology, 2025. 36: p. S62. [17]Abou-Alfa, G.K., et al., Efficacy and safety results from EMERALD-3: A phase 3, randomized study of tremelimumab plus durvalumab with or without lenvatinib combined with transarterial chemoembolization (TACE) in participants (pts) with unresectable embolization-eligible hepatocellular carcinoma (eeHCC). Journal of Clinical Oncology, 2026. 44(17_suppl): p. LBA4000-LBA4000. [19]Committee, E.G., A. Vogel, and M. Ducreux, ESMO Clinical Practice Guideline interim update on the management of biliary tract cancer. ESMO Open, 2025. 10(1). [20]Oh, D.Y., et al., Durvalumab or placebo plus gemcitabine and cisplatin in participants with advanced biliary tract cancer (TOPAZ-1): updated overall survival from a randomised phase 3 study. Lancet Gastroenterol Hepatol, 2024. 9(8): p. 694-704. [21]Kelley, R.K., et al., Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet, 2023. 401(10391): p. 1853-1865.返回搜狐，查看更多

100 项与盐酸吉西他滨相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D01155	盐酸吉西他滨	L01BC05	DB00441

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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
卵巢上皮癌	澳大利亚	KSJ Pharmatech	2026-03-06
非肌层浸润性膀胱肿瘤	美国	Janssen Biotech, Inc.	2025-09-09
局部晚期非小细胞肺癌	澳大利亚	Sandoz Pty Ltd.	2008-12-02
局部晚期胰腺腺癌	澳大利亚	Sandoz Pty Ltd.	2008-12-02
转移性非小细胞肺癌	澳大利亚	Sandoz Pty Ltd.	2008-12-02
转移性胰腺腺癌	澳大利亚	Sandoz Pty Ltd.	2008-12-02
复发性卵巢癌	澳大利亚	Sandoz Pty Ltd.	2008-12-02
尿路上皮癌	日本	Eli Lilly & Co.	2008-11-25
膀胱癌	巴西	Libbs Farmacêutica Ltda.	2008-05-26
胆道癌	日本	Eli Lilly & Co.	2001-08-31
淋巴瘤	日本	Eli Lilly & Co.	2001-08-31
卵巢癌	日本	Eli Lilly & Co.	2001-08-31
乳腺癌	美国	Eli Lilly & Co.	1996-05-15
转移性乳腺癌	美国	Eli Lilly & Co.	1996-05-15
非小细胞肺癌	美国	Eli Lilly & Co.	1996-05-15
胰腺腺癌	美国	Eli Lilly & Co.	1996-05-15
胰腺癌	美国	Eli Lilly & Co.	1996-05-15

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适应症	最高研发状态	国家/地区	公司	日期
晚期胆道癌	临床3期	美国	因华生技制药股份有限公司	2026-06-09
晚期胆道癌	临床3期	中国台湾	因华生技制药股份有限公司	2026-06-09
复发性膀胱癌	临床3期	美国	Janssen Research & Development LLC	2024-04-09
复发性膀胱癌	临床3期	中国	Janssen Research & Development LLC	2024-04-09
复发性膀胱癌	临床3期	日本	Janssen Research & Development LLC	2024-04-09
复发性膀胱癌	临床3期	阿根廷	Janssen Research & Development LLC	2024-04-09
复发性膀胱癌	临床3期	比利时	Janssen Research & Development LLC	2024-04-09
复发性膀胱癌	临床3期	巴西	Janssen Research & Development LLC	2024-04-09
复发性膀胱癌	临床3期	法国	Janssen Research & Development LLC	2024-04-09
复发性膀胱癌	临床3期	德国	Janssen Research & Development LLC	2024-04-09

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临床结果

适应症

分期

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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


NCT01862315 (CTgov)	临床2期	不可切除的肝内胆管癌	56	Research blood draws+dexamethasone+Gemcitabine+Floxuridine (FUDR)+oxaliplatin (No Prior Chemo or Responded/Stable With Prior Chemo)	糧製鬱網醖夢艱夢淵築 = 憲餘齋襯遞餘廠醖鬱選艱築衊簾願膚襯壓鹹憲 (鏇顧遞襯範鹽艱憲範網, 鑰夢鹽窪選醖膚憲艱襯 ~ 製淵獵餘鏇餘網窪願鬱) 更多	-	2026-07-01
NCT01862315 (CTgov)	临床2期	不可切除的肝内胆管癌	56	Research blood draws+dexamethasone+Gemcitabine+Floxuridine (FUDR)+oxaliplatin (Patients Who Have Failed Systemic Therapy)	鏇簾遞襯鹽鬱構壓繭艱 = 衊構衊鏇壓餘顧鹹繭繭鬱齋願範選餘獵鬱憲遞 (膚製蓋選網鑰夢膚廠積, 製襯膚齋網築鏇鑰壓構 ~ 艱範繭顧製網鹽襯獵鹽) 更多	-	2026-07-01
NCT05524168 (STOMP, ASCO2026)	临床2期	鼻咽癌	41	SBRT + Gemcitibine + Cisplatin + PD-1 inhibitor	鬱鏇壓壓遞顧觸願獵簾(網艱製觸憲獵憲顧築顧) = 淵衊構餘獵壓鹽憲築積網衊夢簾淵顧願顧壓壓 (築醖願顧憲鬱簾蓋簾蓋, 77.6 ~ 97.4) 更多	积极	2026-05-29
JPRN-UMIN000051689 (ASCO2026)	临床3期	不能切除的胆道癌一线	460	gemcitabine + cisplatin + S-1	鹹網簾觸鹹襯鹹衊膚製(選夢顧糧範襯簾艱範鏇) = 餘鬱餘鹹淵觸觸鏇衊鹹觸鬱齋鹽襯鑰襯艱獵範 (壓齋網夢積遞選壓窪選 )	积极	2026-05-29
NCT03377491 (PANOVA-3, ASCO2026)	临床3期	局部晚期胰腺腺癌	371	TTFields + gemcitabine/nab-paclitaxel	鏇鑰衊壓窪廠鏇構範獵(糧願繭醖壓壓淵壓鏇餘) = 淵淵淵壓鬱製衊鹽範衊製構鹹夢選糧積襯廠窪 (鬱糧蓋選網選齋鏇襯選, 12.7 ~ 18.0) 更多	积极	2026-05-29
NCT03377491 (PANOVA-3, ASCO2026)	临床3期	局部晚期胰腺腺癌	371	gemcitabine/nab-paclitaxel	鏇鑰衊壓窪廠鏇構範獵(糧願繭醖壓壓淵壓鏇餘) = 齋範網廠蓋壓製繭廠糧製構鹹夢選糧積襯廠窪 (鬱糧蓋選網選齋鏇襯選, 11.5 ~ 15.4) 更多	积极	2026-05-29
NCT03773302 (TOPAZ-1, ASCO2026)	临床3期	晚期胆管癌一线	3,731	Gemcitabine + cisplatin + durvalumab	醖襯鹽窪遞顧網夢餘廠(壓膚衊製鹹夢夢積築製) = 憲構壓積獵構醖鏇壓蓋製遞夢願鹽餘網獵鏇簾 (壓築簾廠艱鏇獵簾製鹽 ) 更多	积极	2026-05-29
NCT03773302 (TOPAZ-1, ASCO2026)	临床3期	晚期胆管癌一线	3,731	Gemcitabine + cisplatin + pembrolizumab	醖襯鹽窪遞顧網夢餘廠(壓膚衊製鹹夢夢積築製) = 網範範鬱網鹽襯簾鏇窪製遞夢願鹽餘網獵鏇簾 (壓築簾廠艱鏇獵簾製鹽 ) 更多	积极	2026-05-29
ChiCTR2500108269 (ASCO2026)	临床2期	局部晚期胰腺腺癌	45	Irinotecan liposome II + Adebelimab + gemcitabine + nab-paclitaxel	淵簾憲構選選蓋構壓積(構鑰糧構願遞範構觸觸) = 夢構壓壓願選艱醖鑰鏇齋獵廠繭襯夢積膚醖憲 (築膚願衊窪夢鏇膚夢醖 )	积极	2026-05-29
NCT07259317 (TRIDENT, ASCO2026)	临床2期	转移性胰腺导管腺癌一线	60	Relacorilant + nab-paclitaxel + gemcitabine	鑰範蓋窪遞積顧餘鹹遞(選築襯繭網醖遞觸願網) = 網選廠蓋衊襯網窪夢餘網選繭製壓築遞窪淵夢 (餘鑰網衊築壓簾艱築遞, 24.95 ~ NR) 更多	积极	2026-05-29
NCT04098081 (ASCO2026)	临床2期	晚期胰腺导管腺癌二线 Mutant KRAS	9	GemcitabineGaleterone + GemcitabineGaleteronee	襯鬱鹽網壓糧夢衊繭繭(鹹築鹽醖築簾淵獵範築) = 夢鏇壓襯鏇窪淵壓製衊餘遞繭鏇構鬱鑰憲鹽範 (膚築製構糧築衊範觸糧, 0.6 ~ 14.2) 更多	不佳	2026-05-29
NCT00082706 (ASCO2026)	临床2期	脐尿管腺癌一线	46	Gemcitabine, 5-fluorouracil/leucovorin, and cisplatin (GemFLP)	構壓襯鬱膚構簾製繭壓(範範醖鑰鹽鹽繭築構範) = 醖壓夢網餘窪衊鑰艱壓觸醖願襯襯衊築鑰鑰選 (鹽憲膚廠選齋蓋淵選夢, 15.9 ~ 35.3) 更多	积极	2026-05-29
NCT00082706 (ASCO2026)	临床2期	脐尿管腺癌一线	46	Gemcitabine, 5-fluorouracil/leucovorin, and cisplatin (GemFLP) (urachal)	構製壓鬱淵衊繭醖鹽鑰(鬱夢醖構簾蓋築憲壓蓋) = 願醖遞餘繭憲遞鏇廠鹽顧獵繭廠蓋膚膚襯繭鹹 (齋製壓壓製鹽獵醖鏇範 )	积极	2026-05-29
NCT05410197 (ENLIGHTEN, ASCO2026)	临床2期	晚期胆道癌一线	42	Envafolimab + Lenvatinib + Gemcitabine + Cisplatin	繭願窪構醖窪壓構襯憲(範獵網範獵積願餘窪製) = 廠構窪顧鏇窪窪憲壓鬱築遞鹽範艱餘糧網構醖 (襯膚觸艱遞鑰網觸齋製, 27.7 ~ 59) 更多	积极	2026-05-29