A Phase II Clinical Trial of Anlotinib in Combination With Platinum-based Chemotherapy in Patients With SMARCA4-Deficient, Locally Advanced or Metastatic Lung Cancer.

The goal of this clinical trial is to evaluate the efficacy and safety of combining Anlotinib with platinum-based chemotherapy for treating locally advanced or advanced lung cancer in patients whose tumors are characterized by SMARCA4 deficiency, as evidenced by the loss of BRG1 protein via immunohistochemistry (IHC). It will also learn about the safety of this combination treatment.
The main questions it aims to answer are:
1. How long can this treatment delay the worsening of the cancer (Progression-Free Survival, PFS)?
2. What side effects or medical problems do participants have when taking this combination? This is a single-arm study, meaning all participants will receive the same investigational combination therapy. Researchers will monitor how well the cancer responds and compare the results to historical data from similar patients who received other treatments.
Participants will:
1. Receive treatment in 21-day cycles: take Anlotinib pills on days 1-14 of each cycle and receive platinum-based chemotherapy by intravenous infusion on day 1 (or days 1 and 8).
2. Undergo regular clinic visits for imaging scans (like CT scans), blood tests, and physical examinations to check the cancer's status and their overall health.
3. Complete questionnaires about their quality of life.
4. Provide tumor tissue and blood samples for exploratory research to understand which patients might benefit most from this treatment.
Treatment will continue until the cancer worsens, side effects become intolerable, the participant decides to withdraw, or the study ends.

开始日期2026-02-01

申办/合作机构

中国医学科学院肿瘤医院

[+1]

NCT07320963

/ Not yet recruiting临床1/2期IIT

A Prospective, Single-Arm, Phase Ib/II Clinical Trial of Chidamide in Combination With Toripalimab and Anlotinib in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma Who Have Failed at Least One Prior Line of Therapy

To explore and evaluate the dose-limiting toxicity (DLT) profile of the fixed-dose combination of toripalimab, anlotinib, and chidamide in patients with recurrent/metastatic nasopharyngeal carcinoma (R/M NPC), and to determine the maximum tolerated dose (MTD) of chidamide, thereby informing subsequent clinical dosing regimens.
To assess the objective response rate (ORR) of the combination regimen in this patient population.

开始日期2026-01-31

申办/合作机构

中山大学

ChiCTR2600116202

/ Not yet recruitingN/AIIT

A Prospective, Single-arm, Exploratory Study of Aipalolitovorilimab Combined with Anlotinib and Low-dose Radiotherapy in the Treatment of Advanced Esophageal Cancer with Prior Immunotherapy Failure.

开始日期2026-01-06

申办/合作机构

安徽省肿瘤医院

100 项与盐酸安罗替尼相关的临床结果

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100 项与盐酸安罗替尼相关的转化医学

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100 项与盐酸安罗替尼相关的专利（医药）

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1,016

项与盐酸安罗替尼相关的文献（医药）

2026-01-06·CLINICAL CANCER RESEARCH

First-line Anlotinib plus Anthracyclines and Ifosfamide Followed by Anlotinib Maintenance in Advanced Soft-Tissue Sarcoma: A Phase II Single-Arm Trial

Article

作者: Wang, Rui ; Zhang, Jian-bo ; Hao, Ting ; Fan, Xiang-chun ; Hu, Wen-yu ; Fu, Heng ; Li, Ming-huan ; Liu, Zeng-jun ; Xu, Xin ; Yuan, Hong-tu ; Liu, Meng-yao ; Xu, Jing ; Wang, Xiang-ying ; Zhang, Hui ; Xu, Ni ; Yang, Chang-sheng ; Zhao, Jun-kai ; Zhou, Lei ; Zhu, Dong-yuan

Abstract:

Purpose::

This study evaluated the efficacy and safety of first-line anlotinib combined with anthracyclines and ifosfamide, followed by anlotinib maintenance therapy, in patients with advanced soft-tissue sarcoma.

Patients and Methods::

Patients received four to six cycles of combination therapy administered every 21 days, comprising anlotinib (12 mg orally daily on days 1–14), anthracyclines (epirubicin 40 mg/m2 daily on days 1–2 or liposomal doxorubicin 30 mg/m2 on day 1), and ifosfamide (2 g/m2 daily on days 1–3). Following induction therapy, patients without disease progression continued anlotinib maintenance until progression, unacceptable toxicity, or death. The primary endpoint was the objective response rate. Secondary endpoints included the disease control rate, progression-free survival, overall survival, and adverse events (AE). The study was registered at the Chinese Clinical Trial Registry (ChiCTR2100054711).

Results::

A total of 52 patients were enrolled. The objective response rate was 30.8% [95% confidence interval (CI), 18.7%–45.1%], and the disease control rate was 82.7% (95% CI, 69.7%–91.8%). With a median follow-up of 29.9 months (95% CI, 24.6–32.3), the median progression-free survival was 6.2 months (95% CI, 2.6–11.2). The median overall survival was not reached (95% CI, 14.4–not estimable). Treatment-related AE of any grade occurred in all patients. The most frequently reported AE included nausea (100%), fatigue (86.5%), and hypoalbuminemia (44.2%). The most common grade 3 to 4 AE included anemia (23.1%), leukopenia (17.3%), and thrombocytopenia (9.6%). No treatment-related deaths occurred.

Conclusions::

First-line anlotinib combined with anthracyclines and ifosfamide, followed by anlotinib maintenance, demonstrated encouraging efficacy with acceptable toxicities in patients with advanced soft-tissue sarcoma, warranting further investigation in randomized controlled trials.

2026-01-01·INTERNATIONAL JOURNAL OF CANCER

An open‐label phase II study: The efficiency and safety of anlotinib + eribulin in patients with HER2 ‐negative metastatic breast cancer

Article

作者: Qu, Fei ; Jin, Nan ; Sun, Chunxiao ; Liang, Yan ; Wu, Xinyu ; Yin, Yongmei ; Lu, Rongrong ; Li, Wei ; Yang, Fan ; Hua, Yijia ; Huang, Xiang

Abstract:

This research (NCT04624711) evaluated the efficacy and safety of eribulin plus anlotinib in patients with HER2‐negative metastatic breast cancer (mBC) and explored the potential synergistic benefits of this combination. A total of 70 women with HER2‐negative breast cancer who had previously undergone anthracycline‐ or taxane‐based therapies were enrolled. Hormone receptor‐positive patients had also received CDK4/6 (Cyclin‐dependent kinase 4/6) inhibitor‐based endocrine therapy. All patients were treated with eribulin mesylate (1.4 mg/m 2 , administered intravenously on days 1 and 8) and anlotinib (12 mg orally, once daily on days 1–14) in 21‐day cycles. The median progression‐free survival (mPFS) was 7.00 months, with an objective response rate (ORR) of 50.00% and a disease control rate (DCR) of 94.29%. Patients with fewer than two visceral metastases exhibited a significantly longer median PFS than those with multiple visceral metastases (8.93 months vs. 6.90 months, p = 0.0337). The most common treatment‐related adverse events (TRAEs) were neutropenia (67.14%) and leukopenia (68.57%), with 41.43% and 27.14% of patients experiencing grade 3/4 hematologic toxicities, respectively. These findings suggest that the combination of eribulin and anlotinib demonstrated encouraging efficacy and a manageable safety profile, offering a potential therapeutic option for patients with HER2‐negative mBC.

2025-12-31·ANNALS OF MEDICINE

A cost-effectiveness analysis of a new and more effective treatment for unresectable hepatocellular carcinoma—from a Chinese perspective

Article

作者: Sun, Guojun ; Chen, Jianhua ; Huang, Zimeng ; Huang, Li ; Shou, Bingchao ; Dong, Zuojun

BACKGROUND:

Anlotinib plus penpulimab has been proven to have good efficacy and safety in the treatment of unresectable hepatocellular carcinoma (uHCC). This study aims to evaluate the cost-effectiveness of anlotinib plus penpulimab compared with sorafenib in the treatment of uHCC from the perspective of the Chinese health system.

METHODS:

Based on the APOLLO clinical trial, a Markov model was constructed, with a simulation time range of 10 years and a cycle of 3 weeks. Costs and quality-adjusted life years (QALYs) were used as model output indicators. The incremental cost-effectiveness ratio (ICER) was calculated through cost-effectiveness analysis, and a willingness-to-pay (WTP) threshold of $37,944.50 was set, which is three times the per capita GDP of China in 2023, to determine the economic feasibility of anlotinib plus penpulimab compared with sorafenib. Sensitivity analysis and scenario analysis were utilized to test the robustness of the model.

RESULTS:

The basic analysis results indicated that the anlotinib plus penpulimab group spent $11,191 more than the sorafenib group but gained 0.56 QALYs. The ICER was $19,983.93/QALY, which was lower than three times the per capita GDP of China. The scenario analysis and sensitivity analysis demonstrated the robustness of the model. In 99.9% of the simulations, the incremental cost of each QALY gained by the anlotinib plus penpulimab group was less than $37,944.50.

CONCLUSION:

Under the threshold of three times China's per capita GDP, anlotinib plus penpulimab is more cost-effective compared with sorafenib.

1,154

项与盐酸安罗替尼相关的新闻（医药）

12 小时之前

·医脉通

长生存·云学院丨林海锋、唐文军教授：以免疫为基石，探索“短程化疗”的联合治疗新策略

回顾2025年世界肺癌大会（WCLC），一项由海南省肿瘤医院林海锋教授和海南医科大学第二附属医院唐文军教授发起的TISAL-FE-01研究值得再次关注。该研究聚探索了替雷利珠单抗联合安罗替尼及2周期化疗用于一线治疗无法根治的IIIB‑IV期非小细胞肺癌（NSCLC），初步数据显示出有前景的疗效与安全性【1】，为临床优化治疗选择提供了参考方向。研究者简介林海锋教授科室主任、主任医师、硕士研究生导师 ● 海南省肿瘤医院肿瘤内科三病区主任 ● 海南省肿瘤防治协会肿瘤免疫与精准治疗专业委员会主任委员 ● 海南省癌症康复与姑息治疗专业主任委员 ● 北京肿瘤防治研究会康复与姑息治疗专业委员会副主任委员 ● 中国肿瘤临床学会（CSCO）神经系统肿瘤专家委员 ● 中国抗癌协会癌症康复与姑息治疗专业委员会委员 ● 以PI身份主持10余项临床研究，临床研究结果多次发布在ASCO上 ● 主持海南科技厅重点项目3项，发表SCI文章10余篇唐文军教授科室负责人、副主任医师、硕士研究生导师 ● 海南医科大学第二附属医院肿瘤内科负责人 ● 以色列RAMBAM医学中心访问学者 ● 海南省医师协会肿瘤内科分会副会长 ● 海南省抗癌协会精准放疗与综合治疗专委会副主任委员 ● 海南省抗癌协会不良反应专委会副主任委员 ● 中华医学会肿瘤支持康复治疗专委会委员 ● 中国抗癌协会癌症康复与姑息治疗专委会委员 ● 中国南方肿瘤临床研究协会（CSWOG）肺癌专委会委员 ● 中国初级卫生保健基金会肺部肿瘤慢性病专委会委员 ● 主持海南省自然科学基金、吴阶平基金等省厅级项目7项，以第一作者或通讯作者发表论文20余篇，发起Ⅱ期抗肿瘤药物临床研究3项，以分中心PI参与Ⅰ～Ⅳ期抗肿瘤药物临床研究40余项。研究背景以PD-(L)1免疫检查点抑制剂为基础的免疫联合化疗已成为驱动基因阴性晚期NSCLC一线标准治疗，相较于化疗，给患者的获益带来了显著的提升【2-3】。如何进一步优化治疗方案，提升患者获益，是临床探讨的热点问题。本研究拟通过免疫治疗联合抗血管生成药物和短疗程化疗，降低化疗毒性的同时，最大化发挥 “1+1+1＞3” 的抗肿瘤协同作用。研究设计本研究是一项单臂的探索性研究，旨在观察替雷利珠单抗联合安罗替尼加用 2 周期化疗治疗不可根治性手术 / 放疗的 IIIB - IV 期 NSCLC 患者的疗效和安全性，主要研究终点为无进展生存期（PFS），次要研究终点为总生存期（OS），客观缓解率（ORR），缓解持续时间（DOR），疾病控制率（DCR）和安全性。图1 研究设计研究结果 2021年 7 月至 2023 年 11 月期间，共纳入 21 例患者，中位年龄为 64 岁（范围：35-74 岁），15/21（71%）的患者组织学类型是非鳞状NSCLC。19/21（90.5%）的患者临床分期为IV期。表1 入组患者基线特征疗效分析：数据截至 2025 年 3 月 7 日，中位随访时间为 24 个月（范围：21 - 34 个月），中位PFS为 11.7 个月（95% CI：8.5 -NR），1 年和 2 年PFS率分别为 46.6% 和 34.9% 。中位OS未达到（95%CI：8.6 -NR），1 年和 2 年OS率分别为 60.2% 和 50.1% 。ORR为 66.7%，DCR为 100%，中位DOR为 7.6 个月。图2 无进展生存期（意向治疗人群）图3 总生存期（意向治疗人群）表2 肿瘤反应评估安全性分析：替雷利珠单抗联合安罗替尼加2周期化疗的治疗方案，整体安全性良好，任意级别的治疗相关不良事件（TRAE）发生率为 19.04%，未观察到≥3级 TRAE以及免疫相关不良事件（irAE）。治疗过程中发生率≥15%不良反应事件（TEAE）的主要包括：白细胞计数减少，中性粒细胞计数降低、手足综合征、口腔溃疡和皮疹等。研究结论替雷利珠单抗联合安罗替尼及 2 周期化疗用于晚期NSCLC一线治疗，展现出良好的疗效和安全性，该方案或可为晚期NSCLC患者治疗优化提供参考。专家点评免疫治疗，给驱动基因阴性的晚期NSCLC带来了全线的获益，从晚期患者后线治疗到一线治疗，再到可手术患者的围术期治疗，免疫治疗不断取得突破，多项临床研究迎来了长随访的生存数据。其中替雷利珠单抗是目前唯一获得一线、二线、围术期适应症且报道长生存数据的药物。替雷利珠单抗联合化疗一线治疗驱动基因阴性晚期NSCLC显著降低了患者的死亡风险33%-47%，4年生存率达到32.8%【4-5】。替雷利珠单抗二线/三线治疗NSCLC，5年OS率高达20.1%【6】。替雷利珠单抗联合化疗对比化疗围术期治疗可切除NSCLC,显著降低死亡风险35%（HR:0.65），4年OS率达到72.3%【7】。这些夯实的生存数据，进一步验证了替雷利珠单抗在驱动基因阴性NSCLC治疗的标准地位，给患者的长生存到治愈带来希望。本研究是一项在免疫治疗的基础上，联合抗血管生成药物和2周期短程化疗一线治疗不可根治性性治疗III-IV期NSCLC的实践优化的探索性研究，旨在降低化疗毒性的同时，最大化发挥 “1+1+1＞3” 的协同抗肿瘤作用,研究结果显示有前景疗效和安全性：中位PFS为 11.7 个月（95% CI：8.5 -NR），1 年和 2 年PFS率分别为 46.6% 和 34.9% 。中位OS未达到（95%CI：8.6 -NR），1 年和 2 年OS率分别为 60.2% 和 50.1% 。ORR为 66.7%，DCR为 100%，中位DOR为 7.6 个月。整体安全性良好，未观察到3 级及以上的TRAE以及irAE，为一线治疗的优化提供了参考。参考文献 J Tang. Phase II Trial of Tislelizumab Combined With Anlotinib and 2-Cycle Chemotherapy as First-Line Treatment for Advanced NSCLC.2025WCLC P1.11.84 Jie Wang. Tislelizumab Plus Chemotherapy vs Chemotherapy Alone as First-line Treatment for Advanced Squamous Non-Small-Cell Lung Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 May 1;7(5):709-717. Shun Lu. Tislelizumab Plus Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC (RATIONALE 304): A Randomized Phase 3 Trial. J Thorac Oncol. 2021 Sep;16(9):1512-1522. S. Lu.Tislelizumab plus chemotherapy as first-line treatment of locally advanced or metastatic nonsquamous non-small-cell lung cancer (final analysis of RATIONALE-304: a randomized phase III trial) ESMO Open. 2024 Oct;9(10):103728 J Wang. Tislelizumab plus chemotherapy versus chemotherapy alone as first-line treatment for advanced squamous non-small-cell lung cancer: final analysis of the randomized, phase III RATIONALE-307 trial. ESMO Open. 2024 Oct;9(10):103727. D Yue. Perioperative Tislelizumab for Resectable Non-small Cell Lung Cancer: Final Analysis of RATIONALE-315.2025 WCLC.MA04.08. D huang.RATIONALE-303: Post-Hoc Analysis of Tislelizumab Monotherapy in Previously Treated Non-Small Cell Lung Cancer With Metastases.2025 WCLC P1.11.46 审校：Squid 排版：Zelda 执行：Zelda 本平台旨在为医疗卫生专业人士传递更多医学信息。本平台发布的内容，不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。如该等信息被用于了解医学信息以外的目的，本平台不承担相关责任。本平台对发布的内容，并不代表同意其描述和观点。若涉及版权问题，烦请权利人与我们联系，我们将尽快处理。

ASCO会议CSCO会议临床结果临床3期引进/卖出

2026-01-08

·良医汇消化肿瘤资讯

【797】重磅！“双安组合”安罗替尼联合派安普利单抗在华获批，开启晚期HCC一线治疗新维度

整理：肿瘤资讯来源：肿瘤资讯 2026年1月5日，正大天晴宣布，盐酸安罗替尼胶囊联合派安普利单抗注射液获得中国国家药品监督管理局（NMPA）批准，用于既往未接受过系统治疗的不可切除或转移性肝细胞癌的治疗。此次获批标志着中国创新药研发从跟跑到并跑的发展进程，作为中国晚期HCC领域的重要里程碑事件，不仅进一步证实了多靶点酪氨酸激酶抑制剂（TKI）联合免疫检查点抑制剂（ICI）作为不可切除HCC一线治疗的应用潜力和临床价值，更通过“卓越疗效获益与良好的安全性特征”双重优势，为晚期肝癌患者提供了兼具疗效突破与安全性保障的优选治疗策略。从临床出发，回归临床： PFS与OS双阳性终点突破肝癌治疗困局直至今日，HCC由于其侵袭性强、预后差，在全球范围内发病率和死亡率仍然居高不下。据数据统计，仅有30%的HCC患者可以接受手术治疗，而不可切除HCC的5年生存率尚不足20%[1]。与此同时，血管侵犯、AFP、肿瘤数目与直径等因素常常与生存预后有直接关联。尤其当HCC伴有大血管侵犯时，严重威胁到患者生存预后，这类患者自然生存期不足半年[2]。目前，HCC系统治疗已从单一靶向迈入靶向免疫联合时代，但进一步提升疗效需多维度突破，针对肝癌大血管侵犯这类比较凶险的疾病，亟需更为安全、有效的治疗方案。安罗替尼+派安普利单抗在华获批，不仅为HCC一线治疗注入了鲜活力量，更为大血管侵犯HCC长生存照进了一缕光亮。此次安罗替尼+派安普利单抗的获批是基于随机、开放、多中心III期临床试验APOLLO研究[3]，该研究旨在评估安罗替尼+派安普利单抗 vs. 索拉非尼一线治疗晚期HCC的疗效与安全性。入组标准为既往未接受过系统治疗的晚期HCC患者，BCLC分期B期（不适合接受局部治疗及手术治疗）或C期，至少具有一个可测量病灶（RECIST 1.1）、ECOG PS：0-1，按照2：1的比例随机分配至安罗替尼+派安普利单抗或索拉非尼。并按大血管侵犯和/或肝外转移、基线AFP（<400 vs. ≥400 ng/mL）、ECOG PS进行分层。主要终点为独立影像评估委员会（IRC）评估的无进展生存期（PFS）、总生存期（OS），次要终点包括研究者评估的PFS、客观缓解率（ORR）、疾病控制率（DCR）、缓解持续时间（DOR）以及安全性。 2025年5月8日，国际顶尖期刊Lancet Oncology在线发表了APOLLO研究的核心成果。截至2024年1月29日，该研究共纳入649例患者，其中试验组433例，对照组216例。与索拉非尼相比，安罗替尼+派安普利单抗显著延长了中位PFS（6.9个月 [95%CI 5.8~8.0个月] vs. 2.8个月 [95%CI 2.7~4.1个月]；HR 0.52 [95%CI 0.41~0.66]；p<0.0001），疾病进展风险显著下降48%[3]。 IRC评估的PFS Kaplan-Meier曲线中位OS也同样被显著延长（16.5个月 [95%CI 14.7~19.0个月] vs. 13.2个月[95%CI 9.7~16.9个月]；HR 0.69 [95%CI 0.55~0.87]；p=0.0014），死亡风险显著降低31%[3]。 OS Kaplan-Meier曲线双安合力铸就APOLLO成功，改写大血管侵犯HCC预后 ICIs的问世彻底改变了HCC的治疗模式，尽管单药ICI相较标准治疗索拉非尼具有更高的持久缓解率，但并未显示出总生存期的改善，由此推动了对ICI联合策略的深入探索。经研究发现，血管内皮生长因子（VEGF）通路、血小板源性生长因子（PDGF）通路、成纤维细胞生长因子（FGF）通路、表皮生长因子受体（EGFR）通路和肝细胞生长因子（HGF）/c-MET通路的异常在HCC的发生发展和复发转移中发挥关键作用。针对这些通路和靶点，多种TKIs被研发出来并投入HCC临床实践。作为一款多靶点TKI，安罗替尼作用靶点集中、IC50值更低：同时抑制肿瘤血管生成和肿瘤细胞增殖，疗效更强、副作用更低。派安普利单抗为新一代PD-1抑制剂，具有高稳定性，低免疫原性，高特异性，高亲和力，无Fc效应的药物特点。经Ib/II期AK105-203研究[4]（NCT04172571）已初步证实安罗替尼+派安普利单抗一线治疗晚期HCC的疗效和安全性。因此，基于寻找提高HCC生存获益的ICI联合策略的迫切需求以及安罗替尼+派安普利单抗在晚期HCC一线治疗中的无限潜力，APOLLO研究应运而生。最终，该研究双主要终点PFS和OS均达到优效界值的卓越成果。此外，基线特征显示，大血管侵犯人群占总人群的41%，明显高于同类研究大血管侵犯人群的入组比例。基线特征众所周知，大血管侵犯对HCC患者生存存在致命的影响。数据显示，门静脉癌栓（PVTT）患者自然生存期仅4.2~5.1个月，肝静脉或下腔静脉癌栓（HVTT/IVCTT）患者更不足3个月，且易因肝功能衰竭或癌栓脱落肺栓塞猝死[2]。而即使大血管侵犯患者接受治疗，预后仍显著更差。但即使在大血管侵犯这一预后极差的亚组中，安罗替尼+派安普利单抗的独特优势更加凸显，将疾病进展风险降低53%（HR 0.47 [95%CI 0.32~0.68]），将中位OS提升6.9个月，死亡风险降低45%（HR 0.55 [95%CI 0.39~0.76]）[5]，上述结果证实了安罗替尼+派安普利单抗组在大血管侵犯高危人群中的显著优势，无疑是这类人群的更优选择。除大血管侵犯患者临床获益显著外，合并其他高危因素的患者，如AFP≥400ng/mL、BCLC分期为C期以及合并HBV感染患者同样观察到了显著的PFS获益和OS获益[3]。值得一提的是，与国内同类研究相比，APOLLO研究入组人群的整体状况更差，且很大一部分患者合并高危因素，在这样不利于研究结果的情况下，依旧将死亡风险降低31%，疾病进展风险降低48%，确切地证实了这一联合方案在控制晚期肝癌疾病进展、延长总生存方面的强大实力。 IRC评估的PFS森林图（事后分析） IRC评估的OS森林图（事后分析）高效低毒获证，实现晚期HCC治疗双重获益近年来，慢病化管理理念已逐步被引入进实体瘤全程管理中，而对于晚期实体瘤患者，一线治疗直接决定了患者的生存期和生活质量。一个高效、低毒的治疗方案，不仅能有效突破“发现即晚期、治疗效果差”的传统困境，更能为患者创造长期带瘤生存的可能。在疗效显著的基础上，降低治疗不良反应，提高患者耐受性于患者而言至关重要。在APOLLO研究中，安罗替尼+派安普利单抗组与索拉非尼组≥3级治疗相关不良事件（TRAEs）的发生率相近。导致药物暂停、剂量下调、停用在两组发生率相近，且索拉非尼组剂量减少的比例更高，免疫相关不良事件（irAEs），安罗替尼+派安普利单抗组的发生率也较低，证实了安罗替尼+派安普利单抗目前剂量的可耐受性以及剂量选择的合理性。安全性数据总的来说，无论是疗效还是安全性，安罗替尼+派安普利单抗这一联合方案作为不可切除HCC一线治疗的潜力已被确立，多个疗效终点一致的结果表明安罗替尼+派安普利单抗较索拉非尼具有临床意义的获益，实现了从“生存期延长”到“生存质量提升”的双重突破。结语 NMPA批准安罗替尼联合派安普利单抗用于不可切除HCC一线治疗，此举不仅为晚期HCC患者提供了疗效确凿且耐受性更优的一线治疗新选择，更通过解决大血管侵犯等高危患者的临床难题，提升了整体治疗格局，更为广大HCC患者提供了一个兼顾长效生存、生活质量与经济负担的优选策略，助力中国肝癌诊疗实践向更高质量发展阶段迈进。参考文献 [1] Wang MD, Xu XJ, et al. Cancer Sci. 2024 Jul;115(7):2159-2169.[2] 合并大血管侵犯肝细胞癌外科治疗的争议与共识. 中国实用外科杂志 2018; 第38卷第2期[3] Zhou J, Bai L, Luo J, Bai Y, et al. Lancet Oncol. 2025 Jun;26(6):719-731.[4] Han C, Ye S, Hu C, et al. Front Oncol. 2021 Jul 13;11:684867.[5] Lee YH, Hsu CY, et al. J Clin Gastroenterol. 2014 Sep;48(8):734-41. 责任编辑：肿瘤资讯-Marie 排版编辑：肿瘤资讯-黄洋洋版权声明版权归肿瘤资讯所有。欢迎个人转发分享，其他任何媒体、网站如需转载或引用本网版权所有内容，须获得授权，且在醒目位置处注明“转自：良医汇-肿瘤医生APP”。

临床结果

2026-01-08

·肿瘤界

2026 ASCO GI即将启幕！一文速览即将登场的86项中国消化肿瘤研究

点击蓝字关注我们前言 2026年美国临床肿瘤学会胃肠道肿瘤研讨会（ASCO GI）将于1月8日至10日（当地时间）在加利福尼亚州旧金山盛大召开。作为全球消化肿瘤领域的顶尖学术盛会，大会旨在为全球肿瘤学者分享前沿研究成果、交流临床实践经验，传递该领域的最新进展与发展趋势。根据已披露的摘要标题，在消化系统肿瘤领域，共有86项中国研究强势登场，广泛涵盖多个癌种。特此整理，期待与广大读者一同聆听即将响起的中国强音。胃食管癌 Oral Abstract Session 01 摘要号：282 Perioperative PD-1 antibody toripalimab combined with chemotherapy versus chemotherapy alone in locally advanced gastric or gastroesophageal junction cancer: 3-year follow-up of the prospective, randomized, phase 2 NEOSUMMIT-01 trial. 围手术期PD-1抗体特瑞普利单抗联合化疗对比单纯化疗治疗局部进展期胃癌或胃食管结合部癌：前瞻性、随机、II期NEOSUMMIT-01试验的3年随访结果讲者：袁庶强 | 中山大学肿瘤防治中心胃食管癌 Rapid Oral Abstract Session 01 摘要号：286 Tislelizumab plus chemoradiotherapy (CRT) versus CRT or chemotherapy (CT) as the neoadjuvant treatment for patients (pts) with locally advanced gastric/gastroesophageal junction adenocarcinoma (GC/GEJC): A multicenter, randomized controlled, open-label, phase Ilb study (TERRIFIC). 替雷利珠单抗联合放化疗（CRT）对比CRT或化疗（CT）作为局部进展期胃/胃食管结合部腺癌（GC/GEJC）患者新辅助治疗的多中心、随机对照、开放性IIb期研究（TERRIFIC）讲者：魏嘉 | 南京鼓楼医院 02 摘要号：289 Adjuvant oxaliplatin with S-1 (SOX) versus S-1 in patients with stage I-III gastric or gastro-oesophageal junction adenocarcinoma (CAPITAL): A randomised, open-label, phase 3 trial. 辅助奥沙利铂联合S-1（SOX方案）对比单用S-1治疗I-III期胃或胃食管结合部腺癌患者的随机、开放标签、III期临床试验（CAPITAL研究）。讲者：聂润聪 | 中山大学肿瘤防治中心 03 摘要号：291 SOX (tegafur plus oxaliplatin) plus anti-PD-1 antibody with or without CAR-like T cell immunotherapy in the treatment of patients with previously untreated metastatic gastric cancer/gastroesophageal junction adenocarcinoma: A multicenter, open-label, randomized, controlled, phase Il trial. SOX（替吉奥联合奥沙利铂）方案联合抗PD-1抗体治疗，辅以或不辅以类CAR-T细胞免疫疗法，用于既往未经治疗的转移性胃癌/胃食管结合部腺癌患者：一项多中心、开放标签、随机对照的II期临床试验。讲者：Qin Lin | 南京鼓楼医院胃食管癌 Poster session 01 摘要号：304 Real-word treatment patterns and biomarker testing landscape of locally advanced gastric/gastroesophageal junction cancer (LA GC/GEJC) in China (SURPASS study). 中国局部晚期胃癌/胃食管交界处癌症(LAGC/GEJC)的真实世界治疗模式和生物标志物检测格局(SURPASS研究) 讲者：苏丹 | 哈尔滨医科大学附属肿瘤医院 02 摘要号：312 A cohort study of concurrent chemoradiotherapy combined with or without immune checkpoint inhibitor in locally advanced esophageal cancer. 一项关于局部晚期食管癌同步放化疗联合或不联合免疫检查点抑制剂的队列研究讲者：Yiping Lin | 南方医科大学南方医院 03 摘要号：314 Adebrelimab with or without induction chemotherapy followed by concurrent chemoradiotherapy for unresectable locally advanced esophageal squamous cell carcinoma (RICE): A prospective, phase 2 trial. 阿得贝利单抗联合或不联合诱导化疗序贯同步放化疗治疗不可切除局部晚期食管鳞状细胞癌（RICE）：一项前瞻性II期临床试验讲者：Shuyi Wu | 中山大学肿瘤防治中心 04 摘要号：337 A novel self-controlled electroacupuncture helmet for chemotherapy-induced cognitive impairment: Results from a prospective randomized trial. 一款用于化疗所致认知障碍的新型自控电针头盔：来自前瞻性随机试验的结果。讲者：Yongling Gong | 南京市第一医院 05 摘要号：344 Neoadjuvant adebrelimab plus SOX and nab-paclitaxel in resectable locally advanced gastric and gastrosophageal junction adenocarcinoma: A multicentre, single-arm, prospective phase Il trial. 新辅助阿得贝利单抗联合SOX方案和白蛋白结合型紫杉醇治疗可切除局部晚期胃及胃食管结合部腺癌：一项多中心、单臂、前瞻性II期临床试验。讲者：Pin Liang | 大连医科大学附属第一医院 06 摘要号：348 Low-dose radiotherapy followed by chemoimmunotherapy in neoadjuvant treatment of locally advanced esophageal squamous cell carcinoma: A phase II STIMULATION-01 clinical trial. 低剂量放疗序贯化学免疫疗法用于局部晚期食管鳞状细胞癌的新辅助治疗：一项II期STIMULATION-01临床试验。讲者：Yong Yuan | 四川大学华西医院 07 摘要号：360 Matching-adjusted indirect comparison of fruquintinib versus ramucirumab in advanced gastric or gastroesophageal junction adenocarcinoma. 经匹配调整的间接比较：呋喹替尼与雷莫西尤单抗在晚期胃癌或胃食管结合部腺癌中的疗效对比。讲者：Nan An | 中山大学肿瘤防治中心 08 摘要号：364 A multicenter, randomized phase 2 study evaluating the efficacy and safety of HLX43 (an anti-PD-L1 ADC) in recurrent/metastatic esophageal squamous cell carcinoma. 一项评估HLX43（一种抗PD-L1抗体药物偶联物）在复发性/转移性食管鳞状细胞癌中疗效与安全性的多中心、随机化II期临床研究。讲者：Linlin Wang | 山东第一医科大学附属肿瘤医院 09 摘要号：368 A phase 2 study of LBL-007 (anti-LAG-3) plus tislelizumab (anti-PD-1) and chemotherapy as first-line treatment in patients with unresectable locally advanced/metastatic esophageal squamous cell carcinoma. 一项关于LBL-007（抗LAG-3抗体）联合替雷利珠单抗（抗PD-1抗体）及化疗作为不可切除局部晚期/转移性食管鳞状细胞癌患者一线治疗的II期临床研究。讲者：巴一 | 北京协和医学院 10 摘要号：369 Phase Ib/ll study of fruquintinib combined with SOX and toripalimab in advanced metastatic gastric/gastrosophageal junction adenocarcinoma (GC/GEJC). 呋喹替尼联合SOX方案及特瑞普利单抗治疗晚期转移性胃/胃食管结合部腺癌（GC/GEJC）的Ib/II期临床研究。讲者：孟祥瑞 | 郑州大学第一附属医院 11 摘要号：371 Three-year outcomes and multi-omics biomarker discovery of locally advanced esophageal squamous cell carcinoma after neoadjuvant chemoradiotherapy and anti-PD-1 antibody from the phase Il trial NEOCRTEC1901. 局部晚期食管鳞状细胞癌新辅助放化疗联合抗PD-1抗体治疗的三年预后及多组学生物标志物发现——来自II期临床试验NEOCRTEC1901的研究结果。讲者：Zihang Mai | 中山大学 12 摘要号：376 Preliminary results of benmelstobart (BEN) combined with concurrent chemoradiotherapy (CRT) versus CRT alone as neoadjuvant therapy for esophageal squamous cell carcinoma (ESCC): A multicentre, randomised study. 贝莫苏拜单抗（BEN）联合同步放化疗（CRT）与单纯CRT作为食管鳞状细胞癌（ESCC）新辅助治疗的初步结果：一项多中心随机研究。讲者：Han Tang | 湖北省中山医院 13 摘要号：377 Tislelizumab (Tisle) combined with POFI (irinotecan, paclitaxel, oxaliplatin, and 5-FU/levoleucovorin) as first-line treatment for advanced gastric/gastroesophageal junction adenocarcinoma (AGC): Update from a single-arm, open-label phase II trial (SYLT-023). 替雷利珠单抗联合POFI方案作为晚期胃/胃食管结合部腺癌（AGC）一线治疗：单臂、开放标签II期试验（SYLT-023）的更新数据讲者：Liyu Su | 福建省肿瘤医院 14 摘要号：382 Efficacy and safety of disitamab vedotin (RC48) in combination with sintilimab and XELOX for perioperative therapy of G/GEJ cancer with HER2 overexpression: Preliminary results of a prospective, single-arm, phase Il study. 维迪西妥单抗（RC48）联合信迪利单抗及XELOX方案用于HER2过表达型胃/胃食管结合部癌围手术期治疗的疗效与安全性：一项前瞻性单臂II期研究的初步结果。讲者：Ying Liu | 郑州大学附属肿瘤医院 15 摘要号：386 Pembrolizumab in combination with chemotherapy as conversion therapy for esophageal squamous cell carcinoma with cervical lymph node metastasis: A single-center, prospective, single-arm, open-label, real-world study. 帕博利珠单抗联合化疗作为转化疗法治疗伴有颈部淋巴结转移的食管鳞状细胞癌：一项单中心、前瞻性、单臂、开放标签的真实世界研究。讲者：Qi Ding | 中国科学技术大学附属第一医院 16 摘要号：391 Clinical significance of oligometastatic esophageal squamous cell carcinoma: A retrospective cohort study. 寡转移性食管鳞状细胞癌的临床意义：一项回顾性队列研究。讲者：Tsung-Che Wu | 台湾大学医学院附属医院新竹分院 17 摘要号：395 Final results of a phase Il study of fruquintinib plus sintilimab as a second-line therapy for advanced gastric and gastrosophageal junction adenocarcinoma (GC/GEJC). 呋喹替尼联合信迪利单抗作为晚期胃癌及胃食管结合部腺癌（GC/GEJC）二线治疗的II期研究最终结果。讲者：Min Jin | 华中科技大学同济医学院 18 摘要号：398 Phase I trial of efficacy and safety of IMC002, a VHH-based anti-CLDN18.2 CAR-T therapy, for gastroesophageal cancers. IMC002（一种基于VHH的抗CLDN18.2 CAR-T疗法）治疗胃食管癌的I期有效性和安全性临床试验讲者：Chao Li | 中国人民解放军总医院 19 摘要号：404 Updated results of anlotinib combined with penpulimab and nab-paclitaxel as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): A single-arm, open-label phase Il clinical trial. 安罗替尼联合派安普利单抗与白蛋白结合型紫杉醇一线治疗晚期食管鳞状上皮细胞癌(ESCC)的最新研究结果：一项单臂、开放标签的II期临床试验讲者：Zhiwei Chang | 郑州大学第一附属医院 20 摘要号：406 Proximal gastrectomy versus total gastrectomy in locally advanced upper gastric cancer after neoadjuvant chemotherapy combined with tislelizumab: The preliminary results of a multicenter, prospective, randomized, phase 3 clinical trial. 新辅助化学疗法联合替雷利珠单抗治疗后，局部进展期胃上部癌行近端胃切除术与全胃切除术比较：一项多中心、前瞻性、随机、III期临床试验的初步结果讲者：王桂华 | 华中科技大学同济医学院 21 摘要号：407 Cadonilimab plus chemotherapy versus PD-1 inhibitor plus chemotherapy as first-line (1L) treatment for advanced gastric (G) or gastroesophageal junction (GEJ) cancer with PD-L1 CPS<5: A propensity-matched, retrospective cohort study. 卡度尼利单抗联合化疗对比PD-1抑制剂联合化疗作为PD-L1 CPS<5的晚期胃癌或胃食管结合部癌一线治疗：一项倾向匹配的回顾性队列研究讲者：Duqin Zhao | 浙江省肿瘤医院 22 摘要号：410 Adebrelimab combined with albumin-paclitaxel and nedaplatin as neoadjuvant therapy for locally advanced resectable esophageal squamous cell carcinoma: A multicenter, single-arm, phase II clinical study. 阿得贝利单抗联合白蛋白结合型紫杉醇和奈达铂作为局部晚期可切除食管鳞状细胞癌的新辅助治疗：一项多中心、单臂、II期临床研究讲者：Jianqun Ma | 哈尔滨医科大学附属肿瘤医院 23 摘要号：411 A prospective, single-arm phase Il study of trilaciclib combined with immunotherapy and chemotherapy as first-line treatment for metastatic/recurrent esophageal squamous cell carcinoma. 一项前瞻性、单臂II期研究：评估曲拉西利联合免疫治疗与化疗作为转移性/复发性食管鳞状细胞癌一线治疗方案的效果。讲者：Yi Wang | 四川省肿瘤医院 24 摘要号：412 Interim analysis of immunomodulatory low-dose radiotherapy plus chemoimmunotherapy as conversion therapy for locally advanced potentially/borderline resectable esophageal squamous cell carcinoma (ROICE trial): A phase Il single-arm study. 局部晚期潜在/临界可切除食管鳞状细胞癌转化治疗中免疫调节性低剂量放疗联合化学免疫疗法的中期分析（ROICE试验）：一项II期单臂研究讲者：任伟 | 南京鼓楼医院 25 摘要号：424 Clinical outcomes and immune contexture in SMARCA4-deficient gastric cancer patients. SMARCA4缺陷型胃癌患者的临床结局与免疫微环境讲者：Hongyong He | 复旦大学附属中山医院 26 摘要号：435 Concordance of programmed death-ligand 1 (PD-L1) status in primary esophageal squamous cell carcinoma (ESCC) and matched visceral metastases. 原发性食管鳞状细胞癌（ESCC）及其匹配内脏转移灶中程序性死亡配体1（PD-L1）状态的一致性讲者：Jhe-Cyuan Guo | 台湾大学医学院附设医院 27 摘要号：452 Non-invasive early detection of gastric cancer using red blood cell DNA genomic signature: A multi-center validation study. 利用红细胞DNA基因组特征无创早期检测胃癌：一项多中心验证研究讲者：Haobo Sun | 西湖大学胃食管癌 Trials in Progress Poster Session 01 摘要号：TPS463 SYLT-030: Efficacy and safety of tislelizumab plus mFOLFOX6 versus tislelizumab plus POF (paclitaxel + mFOLFOX6) as first-line therapy for advanced gastric/gastroesophageal junction adenocarcinoma (AGC): A multicenter, open-label, randomized phase Ill trial. SYLT-030：替雷利珠单抗联合mFOLFOX6对比替雷利珠单抗联合POF（紫杉醇+mFOLFOX6）作为晚期胃/胃食管结合部腺癌（AGC）一线治疗的疗效与安全性：一项多中心、开放标签、随机III期临床试验。讲者：林榕波 | 福建省肿瘤医院肝胆胰肿瘤 Rapid Oral Abstract Session 01 摘要号：655 Integrated penpulimab (a PD-1 inhibitor), anlotinib (an antiangiogenic targeted drug), nab-paclitaxel and gemcitabine as first-line regimen for metastatic pancreatic cancer: A multi-centered, randomized controlled trial (RCT-PAAG). 派安普利单抗（PD-1 抑制剂）、安罗替尼（抗血管生成靶向药）、白蛋白结合型紫杉醇与吉西他滨联合作为转移性胰腺癌一线方案：一项多中心随机对照试验（RCT-PAAG）讲者：杜娟 | 南京鼓楼医院肝胆胰肿瘤 Poster session 01 摘要号：485 Combining the albumin-bilirubin (ALBI) score and ECOG performance status for enhanced prognostication in advanced biliary tract cancer treated with durvalumab-based immunochemotherapy. 联合白蛋白-胆红素（ALBI）评分与 ECOG 体能状态，优化度伐利尤单抗为基础的免疫化疗治疗晚期胆道癌的预后评估讲者：Chi-Chen Lan | 长庚纪念医院 02 摘要号：496 Pathological complete response after systemic conversion therapy and curative resection in initially unresectable hepatocellular carcinoma: Feasibility of a tumor-free for drug-free strategy. 初始不可切除肝细胞癌经全身转化治疗联合根治性切除后的病理完全缓解：“无瘤即停药” 策略的可行性讲者：王骏成 | 中山大学肿瘤防治中心 03 摘要号：499 Efficacy and safety of durvalumab plus gemcitabine/cisplatin in combined hepatocellular-cholangiocarcinoma versus cholangiocarcinoma. 度伐利尤单抗联合吉西他滨/顺铂在混合型肝细胞-胆管癌与胆管癌中的疗效与安全性讲者：Yu-Wei Hsu | 长庚纪念医院 04 摘要号：502 External validation of MAGIC-D in Taiwanese patients with advanced biliary tract cancer receiving durvalumab and chemotherapy. MAGIC-D 模型在接受度伐利尤单抗联合化疗的台湾晚期胆道系统癌患者中的外部验证讲者：Chi-Lin Hsieh | 长庚纪念医院 05 摘要号：506 Transarterial chemoembolization (TACE) combined with sintilimab and bevacizumab versus TACE alone in patients with Barcelona Clinic Liver Cancer stage B unresectable hepatocellular carcinoma: A retrospective, propensity score-matched analysis. 经动脉化疗栓塞（TACE）联合信迪利单抗与贝伐珠单抗 vs 单用 TACE 治疗巴塞罗那临床肝癌分期B期不可切除肝细胞癌：一项回顾性倾向评分匹配分析讲者：蔡鸿杰 | 中山大学附属第一医院 06 摘要号：510 Pattern of progression in advanced hepatocellular carcinoma treated with immunotherapy. 免疫治疗下晚期肝细胞癌的进展模式讲者：Thomas Yau | 香港大学 07 摘要号：511 A simple ABC score for prognosis stratification and treatment selection in advanced hepatocellular carcinoma. 用于晚期肝细胞癌预后分层与治疗选择的简易ABC评分讲者：Yung-Yeh Su | 国家卫生研究院 08 摘要号：536 Toripalimab plus hepatic artery infusion chemotherapy in hepatocellular carcinoma patients of Barcelona Clinic Liver Cancer stage C: A biomolecular exploratory, phase Il trial. 特瑞普利单抗联合肝动脉灌注化疗用于巴塞罗那临床肝癌C期肝细胞癌患者：一项生物分子探索性II期临床试验。讲者：Rongce Zhao | 中山大学肿瘤防治中心 09 摘要号：539 Optimizing the sequencing and timing of transarterial chemoembolization and systemic therapy in advanced hepatocellular carcinoma. 优化经动脉化疗栓塞与系统式治疗在晚期肝细胞癌中的序贯与时机安排。讲者：黄莹莹 | 北京医院 10 摘要号：540 Sequential transarterial chemoembolization and stereotactic body radiotherapy followed by immunotherapy using single tremelimumab regular interval durvalumab in locally advanced, unresectable HCC (START-FIT using STRIDE): A single-arm, phase Il, multi-centre study. 序贯性经动脉化疗栓塞术联合体部立体定向放射治疗，随后采用单次tremelimumab联合固定间隔durvalumab免疫疗法治疗局部晚期不可切除肝细胞癌（START-FIT方案应用STRIDE策略）：一项单臂、II期、多中心临床研究。讲者：Chi Leung Chiang | 香港大学 11 摘要号：549 Donafenib and sintilimab plus transcatheter arterial chemoembolization for unresectable hepatocellular carcinoma: A phase Il, biomarker exploratory study (Dosin TACE). 多纳非尼与信迪利单抗联合经导管动脉化疗栓塞治疗不可切除肝细胞癌：一项II期生物标志物探索性研究（Dosin TACE）。讲者：Xiaoyun Hu | 南方医科大学南方医院 12 摘要号：557 Adjuvant sintilimab plus capecitabine in resected extrahepatic cholangiocarcinoma: Interim report of a single-arm, prospective phase Il study. 辅助性信迪利单抗联合卡培他滨治疗肝外胆管癌切除术后的中期报告：一项单臂前瞻性II期研究。讲者：Jinxue Zhou | 郑州大学附属肿瘤医院 13 摘要号：564 Sintilimab combined with lenvatinib versus hepatic artery infusion chemotherapy (HAIC) for neoadjuvant treatment of resectable hepatocellular carcinoma with high risk of recurrence: A prospective, two-arm, randomized, phase Il clinical study. 信迪利单抗联合仑伐替尼对比肝动脉灌注化疗（HAIC）用于可切除性肝细胞癌伴高复发风险患者的新辅助治疗：一项前瞻性、双臂、随机、II期临床研究。讲者：Feng Fang | 天津医科大学肿瘤医院 14 摘要号：565 Safety and efficacy of hepatic artery infusion chemotherapy (HAIC) or lenvatinib combined with sintlimab as neoadjuvant therapy for high recurrence risk resectable stage IB solitary hepatocellular carcinoma: A prospective, randomized, two-cohort, exploratory phase Il clinical study. 肝动脉灌注化疗（HAIC）或仑伐替尼联合信迪利单抗作为高复发风险可切除IB期孤立性肝细胞癌新辅助治疗的安全性与有效性：一项前瞻性、随机、双队列、探索性II期临床研究。讲者：Yunlong Cui | 天津医科大学肿瘤医院 15 摘要号：569 Outcomes of sarcomatoid hepatocellular carcinoma patients treated with immunotherapy: A multi-institutional retrospective study. 肉瘤样肝细胞癌患者接受免疫治疗的疗效：一项多机构回顾性研究。讲者：Tsung-Hao Liu | 台湾大学医学院 16 摘要号：601 Early detection of hepatocellular carcinoma using red blood cell DNA signatures. 通过红细胞DNA特征早期检测肝细胞癌。讲者：XIngyun Yao | 西湖大学生命科学学院 17 摘要号：634 Real-world efficacy and safety of surufatinib in advanced neuroendocrine neoplasm. 索凡替尼在晚期神经内分泌肿瘤中的真实世界疗效与安全性。讲者：Jiang Long | 上海市第一人民医院 18 摘要号：710 Updated results of the phase 1/2 study of TSN1611, a highly selective KRAS G12D inhibitor, in patients with advanced solid tumors. KRAS G12D高选择性抑制剂TSN1611在晚期实体瘤患者中的I/II期研究更新结果。讲者：Jian Li | 北京大学肿瘤医院 19 摘要号：711 Preoperative NALIRIFOX versus upfront surgery in high-risk resectable pancreatic cancer: A randomized, multi-center trial. 术前NALIRIFOX方案对比直接手术在高风险可切除胰腺癌中的疗效：一项随机多中心临床试验。讲者：Shiwei Guo | 上海长海医院 20 摘要号：718 Preliminary efficacy and biomarker analysis of CLDN18.2-targeted ADC combined with the NET inhibitor sivelestat in female patients with advanced CLDN18.2-positive pancreatic adenocarcinoma. CLDN18.2靶向抗体偶联药物联合NET抑制剂西维来司他钠治疗晚期CLDN18.2阳性胰腺癌女性患者的初步疗效与生物标志物分析。讲者：Jingrui Yan | 天津医科大学肿瘤医院 21 摘要号：719 Preliminary results of ALTER-PA-001 trial: A multicenter, open-label, randomized, phase Il trial of anlotinib and benmelstobart in combination with AG versus AG as first-line treatment for metastatic pancreatic cancer. ALTER-PA-001试验初步结果：一项多中心、开放标签、随机II期临床试验，评估安罗替尼联合贝莫苏拜单抗与AG方案对比AG方案作为转移性胰腺癌一线治疗的疗效。讲者：Jiujie Cui | 上海交通大学医学院附属仁济医院 22 摘要号：720 Efficacy and safety of liposomal irinotecan in patients with advanced pancreatic cancer: A prospective, multicenter, real-world study. 脂质体伊立替康在晚期胰腺癌患者中的疗效与安全性：一项前瞻性、多中心、真实世界研究。讲者：Jin Xu | 复旦大学附属肿瘤医院 23 摘要号：744 A real-world study of claudin 18.2 (CLDN18.2) association with molecular subtypes, mutations/biomarkers, immune landscapes, and gene signatures and prognostic value in pancreatic ductal adenocarcinoma (PDAC). 一项关于紧密连接蛋白18.2（CLDN18.2）与胰腺导管腺癌（PDAC）分子亚型、突变/生物标志物、免疫微环境、基因特征关联及其预后价值的真实世界研究。讲者：Guoqiang Zhang | 安斯泰来制药集团 24 摘要号：748 A phase 2 study of vilanterol in combination with a CLDN18.2 bispecific antibody in patients with advanced CLDN18.2-positive pancreatic ductal adenocarcinoma (PDAC). 维兰特罗联合Claudin18.2双特异性抗体治疗晚期Claudin18.2阳性胰腺导管腺癌（PDAC）的II期研究讲者：Tianxing Zhou | 天津医科大学附属肿瘤医院 25 摘要号：749 A phase 2 study of STING agonist ADU-S100 combined with a CLDN18.2 bispecific antibody in patients with advanced pancreatic cancer. STING激动剂ADU-S100联合CLDN18.2双特异性抗体治疗晚期胰腺癌的II期研究讲者：Tianxing Zhou | 天津医科大学附属肿瘤医院 26 摘要号：750 Predictive value of CLDN18.2+CD8+ T cells in peripheral blood and tumor tissue for immunotherapy response and survival in gastric and pancreatic cancers. 外周血和肿瘤组织中CLDN18.2+CD8+ T细胞对胃癌和胰腺癌免疫治疗反应及生存情况的预测价值讲者：Tianxing Zhou | 天津医科大学附属肿瘤医院 27 摘要号：751 Multicenter prospective validation of PanClaudinAI: An AI for predicting Claudin 18.2 from CT in pancreatic cancer. PanClaudinAI的多中心前瞻性验证：一种基于CT预测胰腺癌中Claudin 18.2的人工智能讲者：Tianxing Zhou | 天津医科大学附属肿瘤医院肝胆胰肿瘤 Trials in Progress Poster Session 01 摘要号：TPS607 Curative therapy after atezolizumab and bevacizumab treatment for unresectable hepatocellular carcinoma: A multinational retrospective study. 阿替利珠单抗联合贝伐珠单抗治疗不可切除肝细胞癌后的根治性治疗：一项多国回顾性研究。讲者：Yu-Yun Shao | 台湾大学医学院附设医院结直肠癌 Oral Abstract Session 01 摘要号：477 Adjuvant pembrolizumab for participants with hepatocellular carcinoma and complete radiologic response after surgical resection or local ablation: The phase 3 keynote-937 study. 帕博利珠单抗辅助治疗经手术切除或局部消融后获得完全影像学缓解的肝细胞癌患者：III期 KEYNOTE-937 研究讲者：陈林 | 香港中文大学结直肠癌 Poster session 01 摘要号：21 Validation of CanCatch Surf assay for tissue-agnostic detection of minimal residual disease in colorectal cancer. CanCatch Surf 检测方法在结直肠癌中泛组织微小残留病检测的验证研究讲者：Shaoyong Dong | 河北大学附属医院 02 摘要号：53 Efficacy and safety of hepatic arterial infusion chemotherapy with FOLFOX or FOLFIRI plus drug-eluting bead transarterial chemoembolization in unresectable colorectal liver metastases. FOLFOX或FOLFIRI方案肝动脉灌注化疗联合载药微球经动脉化疗栓塞治疗不可切除结直肠癌肝转移的疗效与安全性讲者：刘宝将 | 北京大学肿瘤医院 03 摘要号：71 Anastomotic leak and oncologic outcomes after colorectal cancer resection: A real-world analysis. 结直肠癌切除术后吻合口瘘与肿瘤学结局的真实世界分析讲者：Tina T. Lin | 中山医学大学 04 摘要号：118 EMB-01, a tetravalent anti-EGFR/cMET bispecific antibody, in the left-sided, RAS/BRAF wild-type, late-line metastatic colorectal cancer: Subgroup analysis of baseline characteristics and response from a phase 1/2 study. 四价抗EGFR/cMET双特异性抗体EMB-01用于左侧、RAS/BRAF野生型后线转移性结直肠癌：1/2期研究中基线特征与疗效的亚组分析讲者：李健 | 北京大学肿瘤医院 05 摘要号：119 Neoadjuvant chemotherapy and serplulimab in MSS/pMMR locally advanced rectal cancer (FIRM): A phase II trial. 新辅助化疗联合斯鲁利单抗用于MSS/pMMR局部晚期直肠癌（FIRM 研究）：一项II期临床试验讲者：吴庭玉 | 上海交通大学医学院附属新华医院 06 摘要号：121 Cadonilimab combined with FOLFIRINOX and bevacizumab as first-line treatment for microsatellite stable/proficient mismatch repair metastatic colorectal cancer: Updated survival analysis and safety outcomes from a multicenter, single-arm, phase 2 study (SYLT-026). 卡度尼利单抗联合FOLFIRINOX方案与贝伐珠单抗作为微卫星稳定/错配修复功能正常转移性结直肠癌的一线治疗：一项多中心单臂II期研究（SYLT-026）的生存分析更新及安全性结局讲者：Yi Yin | 福建省肿瘤医院 07 摘要号：124 Efficacy and safety of triweekly cetuximab in combination with capecitabine as first-line maintenance treatment for KRAS/BRAF wild-type metastatic colorectal cancer: A phase Ib dose-escalation study. 西妥昔单抗（Q3W）联合卡培他滨作为KRAS/BRAF野生型转移性结直肠癌一线维持治疗的疗效与安全性：一项Ib期剂量递增研究讲者：谢晓煜 | 中山大学附属第六医院 08 摘要号：128 Short-course radiotherapy (SCRT) followed by immunochemotherapy plus fruquintinib as the total neoadjuvant therapy (TNT) for locally advanced rectal cancer (LARC): A multicenter, single-arm, open-label, phase II study (UNION TNT). 短程放疗联合免疫化疗加呋喹替尼作为局部晚期直肠癌的全程新辅助治疗（TNT）：一项多中心、单臂、开放标签的II期研究（UNION TNT）讲者：张涛 | 华中科技大学同济医学院附属协和医院 09 摘要号：131 Progression-free survival with the ICE regimen in refractory RAS/BRAF wild-type and MSS mCRC patients. ICE方案用于难治性RAS/BRAF野生型及微卫星稳定转移性结直肠癌患者的无进展生存期讲者：黄莹莹 | 北京医院 10 摘要号：145 Surgical efficacy of neoadjuvant mono-immunotherapy for T₄-deficient mismatch repair colon cancer: A prospective, single-arm, phase II trial. 新辅助单药免疫治疗用于T₄期错配修复缺陷型结肠癌的手术疗效：一项前瞻性、单臂II期试验讲者：孙振 | 北京协和医院 11 摘要号：147 Neoadjuvant short-course radiotherapy combined with CAPOX and PD-1 inhibitor for MSS/pMMR high-risk locally advanced colon cancer: A randomized, prospective, multicentre, phase II trial (TORCH-C). 新辅助短程放疗联合CAPOX方案与PD-1抑制剂用于MSS/pMMR 高危局部晚期结肠癌：一项随机、前瞻性、多中心II期试验（TORCH-C）讲者：张慧 | 复旦大学附属肿瘤医院 12 摘要号：148 Second-line Irinotecan followed by third-line cetuximab plus irinotecan versus second-line cetuximab combined with irinotecan in treatment of oxaliplatin/5-FU failure RAS/RAF wild-type mCRC patients: A randomized phase II study. 奥沙利铂/5-氟尿嘧啶治疗失败的RAS/RAF野生型转移性结直肠癌患者中，二线伊立替康序贯三线西妥昔单抗联合伊立替康 vs 二线西妥昔单抗联合伊立替康的对比：一项随机II期研究讲者：李文桦 | 复旦大学附属肿瘤医院 13 摘要号：154 Circulating tumor DNA to guide rechallenge with cetuximab plus irinotecan in Chinese RAS/BRAF wild type metastatic colorectal cancer: A phase II trial. 循环肿瘤DNA指导西妥昔单抗联合伊立替康在国内RAS/BRAF野生型转移性结直肠癌中的再挑战治疗：一项II期试验讲者：李宇红 | 中山大学肿瘤防治中心 14 摘要号：157 Regorafenib combined with trifluridine/tipiracil versus regorafenib monotherapy in refractory metastatic colorectal cancer (FDZL-REGOT): A randomized phase 2 trial. 瑞戈非尼联合曲氟尿苷/替匹嘧啶 vs 瑞戈非尼单药治疗难治性转移性结直肠癌（FDZL-REGOT 研究）：一项随机II期试验讲者：王辰辰 | 复旦大学附属肿瘤医院 15 摘要号：173 Sequencing fruquintinib and trifluridine/tipiracil to improve outcomes in the real-world management of MMR-proficient, chemo-refractory colorectal cancer in Hong Kong. 香港地区错配修复功能正常、化疗难治性结直肠癌的真实世界管理中，呋喹替尼与曲氟尿苷/替匹嘧啶的序贯治疗以改善结局讲者：Jenny Lo | 香港大学 16 摘要号：184 Efficacy and safety of pralsetinib in RET fusion-positive solid tumors: Data from the TAPISTRY trial. 普拉替尼在RET融合阳性实体瘤中的疗效与安全性：来自TAPISTRY试验的数据讲者：Chia-Chi Lin | 台湾大学 17 摘要号：188 Influence of the NECTIN2-TIGIT axis on resistance to PD-L1 blockade combined with chemoradiotherapy in MSS locally advanced rectal cancer. NECTIN2-TIGIT轴对微卫星稳定型局部晚期直肠癌中PD-L1抑制剂联合放化疗耐药性的影响讲者：Zhehui Zhu | 复旦大学附属中山医院 18 摘要号：206 Multi-omics characterization of response to tyrosine kinase inhibitor plus immunotherapy in MSS/pMMR metastatic colorectal cancer: A multicenter biomarker study. 微卫星稳定/错配修复功能正常转移性结直肠癌中酪氨酸激酶抑制剂联合免疫治疗应答的多组学特征分析：一项多中心生物标志物研究讲者：Zhihao Hu | 陆军军医大学 19 摘要号：299 Single-cell sequencing to reveal immune features of treatment response to neoadjuvant chemoradiotherapy plus immunotherapy in locally advanced rectal cancer. 单细胞测序揭示局部晚期直肠癌中新辅助放化疗联合免疫治疗应答的免疫特征讲者：Qianyu Wang | 中国人民解放军总医院 20 摘要号：230 Influence of multiomics on tumor microenvironment remodeling in locally advanced rectal cancer following neoadjuvant chemoradiotherapy plus immunotherapy. 多组学对局部晚期直肠癌新辅助放化疗联合免疫治疗后肿瘤微环境重塑的影响讲者：Na Tian | 中国人民解放军总医院结直肠癌 Trials in Progress Poster Session 01 摘要号：TPS258 Phase II trial of neoadjuvant short-course radiotherapy followed by ivonescimab with or without chemotherapy in locally advanced rectal cancer (TRIUNITE-03). 局部晚期直肠癌中新辅助短程放疗序贯依沃西单抗联合或不联合化疗的II期试验（TRIUNITE-03 研究）讲者：Haode Shen | 陆军军医大学陆军特色医学中心 (大坪医院) 02 摘要号：TPS261 TRIUNITE-02: A phase 2, open-label, randomized study of neoadjuvant CAPEOX plus tislelizumab and chidamide versus CAPEOX alone in previously untreated, resectable, locally advanced mismatch repair-proficient/microsatellite stable colon cancer. TRIUNITE-02研究：未接受过治疗、可切除的局部晚期错配修复功能正常/微卫星稳定型结肠癌中，新辅助CAPEOX方案联合替雷利珠单抗与西达本胺 vs 单用 CAPEOX 的II期开放标签随机研究讲者：Zhuo Chen | 陆军军医大学陆军特色医学中心 (大坪医院) 03 摘要号：TPS271 Reducing the resection range after neoadjuvant therapy for locally advanced upper rectal and rectosigmoid junction cancers (RESET): A prospective, multicenter, randomized controlled phase 3 study. 局部晚期高位直肠癌与直肠乙状结肠交界处癌新辅助治疗后缩小切除范围（RESET 研究）：一项前瞻性、多中心、随机对照III期研究讲者：Zhiming Liu | 中山大学附属第六医院 04 摘要号：TPS272 Phase II trial of neoadjuvant short-course radiotherapy followed by ivonescimab with or without chemotherapy in locally advanced rectal cancer (TRIUNITE-03). 局部晚期直肠癌中新辅助短程放疗序贯依沃西单抗联合或不联合化疗的II期试验（TRIUNITE-03 研究）讲者：Haode Shen | 陆军军医大学陆军特色医学中心 (大坪医院) 备注：排名不分先后，按照摘要号进行排序如有遗漏或任何问题，请给我们留言~ 声明：本文由“肿瘤界”整理与汇编，欢迎分享转载，如需使用本文内容，请务必注明出处。来源：医脉通消化系统肿瘤编辑：Lagertha 审核：素问

免疫疗法ASCO会议临床2期细胞疗法临床结果

100 项与盐酸安罗替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XE	DB11885

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
晚期肝细胞癌	中国	正大天晴药业集团股份有限公司	2025-12-30
转移性肾细胞癌	中国	正大天晴药业集团股份有限公司	2025-05-13
不可切除的肾细胞癌	中国	正大天晴药业集团股份有限公司	2025-05-13
子宫内膜癌	中国	正大天晴药业集团股份有限公司	2024-11-22
广泛期小细胞肺癌	中国	正大天晴药业集团股份有限公司	2024-05-08
分化型甲状腺癌	中国	正大天晴药业集团股份有限公司	2022-04-08
甲状腺髓样癌	中国	正大天晴药业集团股份有限公司	2021-01-30
小细胞肺癌	中国	正大天晴药业集团股份有限公司	2019-09-01
软组织肉瘤	中国	正大天晴药业集团股份有限公司	2019-07-01
非小细胞肺癌	中国	正大天晴药业集团股份有限公司	2018-05-14
局部晚期非小细胞肺癌	中国	正大天晴药业集团股份有限公司	2018-05-08
转移性非小细胞肺癌	中国	正大天晴药业集团股份有限公司	2018-05-08

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
肺泡软组织肉瘤	申请上市	中国	正大天晴药业集团股份有限公司	2025-08-23
晚期鳞状非小细胞肺癌	申请上市	中国	正大天晴药业集团股份有限公司	2025-04-23
非小细胞肺癌 III期	申请上市	中国	正大天晴药业集团股份有限公司	2025-04-23
局限期小细胞肺癌	临床3期	中国	正大天晴药业集团股份有限公司	2024-09-01
原发性腹膜癌	临床3期	美国	南京爱德程宁欣药物研发有限公司	2022-04-06
原发性腹膜癌	临床3期	美国	正大天晴药业集团股份有限公司	2022-04-06
原发性腹膜癌	临床3期	中国	正大天晴药业集团股份有限公司	2022-04-06
原发性腹膜癌	临床3期	中国	南京爱德程宁欣药物研发有限公司	2022-04-06
原发性腹膜癌	临床3期	意大利	正大天晴药业集团股份有限公司	2022-04-06
原发性腹膜癌	临床3期	意大利	南京爱德程宁欣药物研发有限公司	2022-04-06

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临床结果

适应症

分期

评价

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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


NCT04213118 (ALTER-H004, Pubmed \| Clin Transl Oncol)	临床2期	肝细胞癌辅助	29	Anlotinib plus TACE	醖窪觸醖築鏇鏇夢膚膚(艱選衊艱構膚積製繭構) = 網壓觸淵壓鹽顧網鹽襯觸憲範襯膚蓋膚蓋簾製 (衊獵顧遞鹽獵廠鑰廠遞, 50.2 ~ 85.6) 更多	积极	2026-01-03
ESMO_ASIA2025	N/A	晚期非小细胞肺癌	270	Anlotinib plus SOC	齋衊遞積艱廠鹹衊鑰鏇(鑰膚製鏇窪壓襯鹹選築) = Most adverse events were grade 1-2, including hypertension (27.4%), elevated ALP (16.6%), elevated AST (12.8%). No new safety signals were observed. 膚壓膚觸憲構鹽窪觸範 (鏇膚獵夢網糧衊範鏇製 ) 更多	积极	2025-12-05
ESMO_ASIA2025	N/A	晚期非小细胞肺癌	270	SOC alone		积极	2025-12-05
NCT05311579 (ESMO_ASIA2025)	临床2期	卵巢癌一线 \| 维持	22	AnlotinibNiraparib + AnlotinibNiraparib	壓簾鬱選顧範蓋積鏇壓(淵遞製積窪範襯鬱願鏇) = 鏇衊網遞餘淵簾蓋齋選遞繭顧蓋製遞餘製積製 (淵觸構憲壓蓋構鹹構蓋 ) 更多	积极	2025-12-05
ChiCTR2300076386 (ESMO_ASIA2025)	临床1期	晚期非小细胞肺癌 HER2-varianted	21	RC48 + Anlotinib	鹽糧構醖廠鏇鹹夢餘簾(願糧鬱壓襯艱鏇構獵糧) = 願淵膚選鏇艱齋觸鏇窪糧艱壓淵範蓋衊顧淵窪 (積築齋艱淵壓積膚構壓 ) 更多	积极	2025-12-05
ESMO2025 人工标引	N/A	平滑肌肉瘤 \| 晚期脂肪肉瘤	22	EribulinEribulin + Anlotinib	鑰遞鏇繭鏇鹹網觸遞願(壓廠襯鏇淵膚構築夢鑰) = 衊壓製願鏇餘選壓齋鏇蓋壓鹽淵顧壓觸鹽糧鏇 (窪選鑰築積構廠網憲鹽, 0.6 ~ 14) 更多	积极	2025-10-17
ESMO2025 人工标引	N/A	平滑肌肉瘤 \| 晚期脂肪肉瘤	22	EribulinEribulin + Anlotinib (LMS)	鑰遞鏇繭鏇鹹網觸遞願(壓廠襯鏇淵膚構築夢鑰) = 遞膚餘憲醖願鹹鑰觸鏇蓋壓鹽淵顧壓觸鹽糧鏇 (窪選鑰築積構廠網憲鹽, 2.0 ~ 4.8) 更多	积极	2025-10-17
ChiCTR2200067045 (ESMO2025) 人工标引	临床2期	甲状腺未分化癌 BRAF Gene Mutation Negative	19	SintilimabAnlotinib + SintilimabAnlotinibb	蓋繭窪鬱糧壓遞鬱網鹽(顧選顧繭衊鬱餘夢蓋製) = 蓋淵範選憲獵艱願醖夢壓願糧顧顧製繭鑰構鑰 (憲網築窪築觸築積壓廠 ) 更多	积极	2025-10-17
NCT05075512 (ESMO2025) 人工标引	临床2期	HR阳性/HER2阴性乳腺癌 HR Positive \| HER2 Negative	40	Anlotinib + FulvestrantFulvestrant	簾願夢鏇簾襯遞築膚簾(積淵衊顧選窪齋壓窪夢) = 構願網鹽築鑰餘範製鏇廠網顧顧廠餘蓋獵襯糧 (齋製遞膚鹹齋憲夢繭範, 3.5 ~ 8.3) 更多	积极	2025-10-17
NCT05075512 (ESMO2025) 人工标引	临床2期	HR阳性/HER2阴性乳腺癌 HR Positive \| HER2 Negative	40	Anlotinib + FulvestrantFulvestrant (Not previously received CDK4/6i)	簾願夢鏇簾襯遞築膚簾(積淵衊顧選窪齋壓窪夢) = 構顧遞壓糧醖衊鹽餘齋廠網顧顧廠餘蓋獵襯糧 (齋製遞膚鹹齋憲夢繭範 )	积极	2025-10-17
ChiCTR2000035072 (ESMO2025) 人工标引	临床2期	铂耐药上皮性卵巢癌	17	Sintilimab + PaclitaxeAnlotinibinib	淵範遞觸夢糧齋繭夢憲(夢範繭蓋餘憲選願積鏇) = 衊壓鹽餘鹽願鏇遞淵餘築積夢淵積夢構膚網積 (選齋積鹽築範襯鬱艱鑰, 3.5 ~ NR) 更多	积极	2025-10-17
NCT06621095 (ALTER-PA-001, ESMO_IO2025)	临床2期	转移性胰腺癌一线	43	Anlotinib + Benmelstobart + AG regimen	膚衊窪範鬱遞製選觸鏇(願簾構壓網膚糧鹽蓋選) = 獵鏇廠鹹糧夢簾艱蓋壓願窪艱選構糧餘願憲網 (壓構鹽積廠積窪簾醖窪 ) 更多	积极	2025-10-12
NCT06621095 (ALTER-PA-001, ESMO_IO2025)	临床2期	转移性胰腺癌一线	43	AG regimen	膚衊窪範鬱遞製選觸鏇(願簾構壓網膚糧鹽蓋選) = 積鹹糧鹹簾繭蓋餘醖窪願窪艱選構糧餘願憲網 (壓構鹽積廠積窪簾醖窪 ) 更多	积极	2025-10-12
ESMO_IO2025	临床2期	非小细胞肺癌	26	AnlotinibCadonilimab + AnlotinibCadonilimab (locally advanced or metastatic NSCLC)	網憲觸窪壓夢餘糧蓋醖(齋淵簾壓願鏇獵襯憲獵) = 膚醖範製築醖襯顧廠窪範遞積淵齋鬱壓糧蓋壓 (壓範餘餘齋繭憲壓積築 ) 更多	积极	2025-10-12