Toripalimab With Sequential Intravesical Gemcitabine-Mitomycin C Versus Toripalimab Alone for the Treatment of BCG-Unresponsive/-Intolerant High-Risk Non-Muscle-Invasive Bladder Cancer: An Open-Label, Randomized, Multicenter, Phase 2 Study

This open-label, randomised, multicentre, phase 2 study (OHAI-NMIBC-01) compares toripalimab plus sequential intravesical gemcitabine followed by mitomycin C (GEM→MMC) with toripalimab alone in adults with BCG-unresponsive or BCG-intolerant high-risk non-muscle-invasive bladder cancer (HR-NMIBC). Two prespecified cohorts are analysed: (1) CIS cohort (CIS with/without Ta/T1) and (2) non-CIS cohort (high-risk Ta/T1 without CIS). In the combination arm, intravesical GEM→MMC is given weekly for 6 weeks (induction) and, for patients without recurrence at the first tumour assessment (
month 3), monthly maintenance continues up to 24 months or until progression/unacceptable toxicity; toripalimab IV every 3 weeks starts during the first intravesical cycle and continues up to 24 months or until progression/unacceptable toxicity. The monotherapy arm receives toripalimab IV every 3 weeks up to 24 months or until progression/unacceptable toxicity. Cystoscopy and urine cytology are performed every 3 months; imaging every 24 weeks. Primary endpoints are 3-month complete response (CR) rate in the CIS cohort and median recurrence-free survival (RFS) in the non-CIS cohort. Secondary endpoints include landmark CR, PFS and OS, RFS/HG-RFS landmarks in the non-CIS cohort, and safety (CTCAE v5.0). Exploratory analyses will assess outcomes by protocol-defined PD-L1 status. Approximately 106 participants will be enrolled at multiple sites in China.

开始日期2026-12-01

申办/合作机构

温州医科大学附属第一医院

NCT07819578

/ Not yet recruiting临床2期IIT

A Phase II Study of Toripalimab Combined With Sacituzumab Tirumotecan as Neoadjuvant Therapy for Resectable Non-Small Cell Lung Cancer

This is a prospective, multicenter, single-arm Phase II investigator-initiated trial evaluating neoadjuvant toripalimab plus sacituzumab tirumotecan (SKB264) in treatment-naive adults with resectable or potentially resectable, driver-negative non-small cell lung cancer (NSCLC). Eligible participants have stage II-IIIA or selected IIIB disease (T3N2 or T4N2) and will receive sacituzumab tirumotecan 5 mg/kg plus toripalimab 3 mg/kg intravenously on Day 1 every 2 weeks for up to 6 cycles. Participants deemed operable after multidisciplinary assessment will undergo definitive surgery. The primary endpoint is pathologic complete response. A Simon two-stage minimax design plans to enroll 30 participants.

开始日期2026-10-01

申办/合作机构

中山大学

[+2]

ChiCTR2600133080

/ Not yet recruitingN/AIIT

Clinical Trial of ALA-PDT Combined with Immunotherapy for Locally Advanced and Metastatic cSCC

开始日期2026-10-01

申办/合作机构

上海皮肤病医院长宁区门诊部

[+1]

100 项与特瑞普利单抗相关的临床结果

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100 项与特瑞普利单抗相关的转化医学

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100 项与特瑞普利单抗相关的专利（医药）

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652

项与特瑞普利单抗相关的文献（医药）

2026-12-31·Human Vaccines & Immunotherapeutics

Cost‑effectiveness of first‑line immunotherapy-based combination regimens for advanced renal cell carcinoma in China and the United States

Article

作者: Yan, Chunyan ; Zhao, Quan ; Li, Jiayan ; Diao, Ruigang ; Gao, Yuan ; Li, Zhengxiong

Immunotherapy‑based combination regimens provide significant clinical benefits but impose substantial economic burdens on national healthcare systems. This study assessed the cost-effectiveness of immunotherapy‑based combination regimens as first-line treatments for advanced renal cell carcinoma (aRCC) in China and the United States (US). A partitioned survival model was developed to evaluate the cost-effectiveness of all approved regimens with a lifetime horizon. The primary outcomes were total costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). Sensitivity analyses were performed to evaluate model uncertainty. Compared to the sunitinib regimen, the ICERs for the toripalimab plus axitinib (T + A), nivolumab plus ipilimumab (N + I), lenvatinib plus pembrolizumab (L + P), pembrolizumab plus axitinib (P + A), nivolumab plus cabozantinib (N + C), avelumab plus axitinib (A + A) and atezolizumab plus bevacizumab (A + B) regimens in China were $64,536.98/QALY, $135,593.25/QALY, $174,956.58/QALY, $231,908.95/QALY, $728,876.75/QALY, $1,232,070.43/QALY, and $2,496,799.42/QALY, respectively. The ICERs for the N + I, T + A, N + C, P + A, L + P, A + A, and A + B regimens in the US were $160,243.50/QALY, $468,156.65/QALY, $804,963.69/QALY, $907,549.79/QALY, $2,170,769.66/QALY, $2,623,809.39/QALY, and $12,712,147.95/QALY, respectively. Probabilistic sensitivity analyses indicated that the probability of cost-effectiveness corresponding to N + I vs. sunitinib was 33.6% in the US. In China and the US, none of the seven first-line immunotherapy-based combination regimens was cost-effective compared with sunitinib for aRCC.

2026-09-01·JOURNAL OF INORGANIC BIOCHEMISTRY

Copper (I) nicotinate complex potentiates chemotherapy-induced apoptosis in HCC-1806 triple negative breast cancer cells: An in vitro study

Article

作者: Abdel-Mohsen, Mohamed A ; Helal, Marihan A ; Toson, Elshahat A

Triple negative breast cancer (TNBC) remains a clinically challenging subtype because it lacks established molecular targets and often depends on cytotoxic chemotherapy. Although doxorubicin (DOX) and mTOR inhibitors such as Torin1 (TOR) exhibit antitumor activity, their clinical use may be constrained by toxicity and resistance. Copper (I) Nicotinate Complex (CNC) has emerged as promising candidates due to their superoxide dismutase (SOD) -mimicking and cytoprotective properties. This study aimed to evaluate the potential effect of CNC combined with DOX or TOR to enhance cytotoxicity against HCC-1806 cells while reducing individual drug dosages. Cell viability was assessed via MTT assay. Drug interactions were analyzed by combination index methodology. Mechanistic responses were evaluated using Annexin V/PI flow cytometry, cell cycle analysis, Comet assay, and biochemical quantification of Caspase-3, Survivin, pCHK1^ser317, and SOD activity. CNC containing combinations enhanced cytotoxic responses relative to selected single-agent conditions, with ratio-dependent additive or synergistic interactions. Combination treatments increased apoptotic populations, altered cell cycle progression with enrichment of sub G0-G2/M fractions, and elevated DNA damage associated markers, including comet tail moment and pCHK1^ser317. CNC inclusive regimens also increased caspase-3 activity and reduced survivin expression. Increased SOD activity indicated modulation of oxidative stress related responses. Exploratory analysis showed treatment-associated changes in PD-1 expression. In conclusion, these findings provide preliminary in vitro evidence that CNC may potentiate selected anticancer responses of DOX or TOR in HCC-1806 cells through apoptosis-associated, cell cycle, and DNA damage-related mechanisms. Further validation in additional TNBC models and in vivo systems is required.

2026-08-01·LANCET ONCOLOGY

Neoadjuvant toripalimab plus celecoxib versus toripalimab monotherapy for mismatch repair-deficient or microsatellite instability-high, locally advanced colorectal cancer (PICC-2): an open-label, multicentre, randomised, phase 2 trial

Article

作者: Deng, Yanhong ; Kang, Liang ; Wang, Huaiming ; Zhai, Xiaohui ; Wang, Hui ; Cao, Wuteng ; Li, Shanshan ; Shen, Xutao ; Wu, Xiaojian ; Li, Jianxia ; Huang, Yan ; He, Xiaosheng ; Chen, Dianke ; Deng, Jiaye ; Yang, Zuli ; Huang, Meijin ; Shi, Lishuo ; Li, Yunfeng ; Hou, Yujie ; Hu, Huabin ; Li, Weiwei ; Zhou, Jiaming ; Luo, Shuangling ; Li, Fangqian ; He, Zhen ; Hu, Jiancong ; Ling, Li ; Zheng, Zhuoxin ; Huang, Liang ; Deng, Weihao ; Liu, Ping ; Xie, Xiaoyu ; Lan, Ping ; Zhang, Yan ; Yang, Tao ; Wang, Chao ; Zhang, Jianwei ; Wang, Xiaozhong

BACKGROUND:

Neoadjuvant immune checkpoint blockade has shown remarkable activity in mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H), locally advanced colorectal cancer. Preclinical studies suggest that COX-2 inhibition might modulate the inflammatory tumour microenvironment and augment the effect of PD-1 blockade. We aimed to investigate whether the addition of the COX-2 inhibitor celecoxib to neoadjuvant toripalimab would increase the pathological complete response in this population.

METHODS:

PICC-2 was a multicentre, open-label, randomised, controlled, phase 2 trial conducted at three academic hospitals in China. Eligible patients were aged 18-75 years; had histologically confirmed dMMR or MSI-H colorectal cancer, of clinical stage T3-T4 or any clinical T stage with lymph node positivity (N+); had an Eastern Cooperative Oncology Group performance status score of 0 or 1; and had adequate haematological, hepatic, and renal function. Participants were randomly assigned (1:1) via an interactive web response system, stratified by tumour location and clinical T stage, to receive neoadjuvant toripalimab plus celecoxib or toripalimab monotherapy every 14 days for 12 cycles, followed by surgery. Toripalimab 3 mg/kg was administered intravenously on day 1 in both groups; patients in the toripalimab plus celecoxib group also received celecoxib 200 mg orally twice daily on days 1-14. The primary endpoint was the proportion of patients with pathological complete response, defined as no presence of residual viable tumour in the primary tumour and all sampled lymph nodes at surgery, assessed by central blinded independent pathological review in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of study treatment. This study is registered with ClinicalTrials.gov, NCT03926338, and is ongoing.

FINDINGS:

Between May 5, 2022, and Jan 20, 2025, 110 patients were randomly assigned to toripalimab plus celecoxib (n=55) or toripalimab monotherapy (n=55). Overall, 65 (59%) patients were male, all patients were Chinese, 76 (69%) had cT4 tumours, and 105 (95%) had clinically node-positive disease. At the data cutoff date (Oct 10, 2025), median follow-up was 18·1 months (IQR 11·5-25·3). 49 (89%) of 55 patients in each group completed all 12 planned cycles of neoadjuvant therapy. Surgery was done in 53 (96%) of 55 patients in the toripalimab plus celecoxib group and 51 (93%) of 55 in the monotherapy group. Pathological complete response was observed in 49 of 55 patients (89% [95% CI 78-96]) in the toripalimab plus celecoxib group versus 38 of 55 (69% [55-81]) in the monotherapy group (between-group difference 19 percentage points [95% CI 4-34]; p=0·014). Grade 3 treatment-related adverse events occurred in three (5%) patients and four (7%) patients, respectively; grade 3 treatment-related adverse events were tumour perforation (two [4%]) and bowel obstruction (one [2%]) in the toripalimab plus celecoxib group, and rash (one [2%]), tumour perforation (one [2%]), increased aminotransferase (one [2%]), and hypothyroidism (one [2%]) in the monotherapy group. No grade 4 or 5 treatment-related adverse events occurred.

INTERPRETATION:

In patients with dMMR or MSI-H locally advanced colorectal cancer, neoadjuvant toripalimab plus celecoxib significantly increased the proportion of patients attaining pathological complete response compared with toripalimab monotherapy, with a similar safety profile. These findings support further investigation of this combination strategy in larger phase 3 trials.

FUNDING:

The National Natural Science Foundation of China, Guangdong Basic and Applied Basic Research, the National Key Clinical Discipline of China, the Program of Guangdong Provincial Clinical Research Center for Digestive Diseases, and the Chinese Society of Clinical Oncology-Junshi Biosciences Oncology Immunity Research.

TRANSLATION:

For the Chinese translation of the abstract see Supplementary Materials section.

4,894

项与特瑞普利单抗相关的新闻（医药）

2026-09-23

·微信

2026 CSCO | GC101 TIL研究荣膺优秀论文一等奖暨2026创新研究奖，斯璐教授解读GC101 TIL疗法如何破局PD-1耐药黑色素瘤

2026年9月17日至19日，第29届中国临床肿瘤学会（CSCO）学术年会在山东济南召开，本次大会聚焦肿瘤临床前沿，交流实践经验，分享研究成果。在恶性黑色素瘤专场，北京大学肿瘤医院主任医师、博士生导师斯璐教授，以“自体肿瘤浸润淋巴细胞（GC101 TIL）在PD-1抗体耐药晚期黑色素瘤中的疗效与安全性：一项多中心、开放标签、随机对照的关键Ⅱ期临床试验（MIZAR-003）”为题，汇报了GC101 Ⅱ期研究的数据结果。该研究凭借严谨的随机对照设计与突出的临床价值，荣获本届CSCO年会优秀论文一等奖，并同时斩获2026 CSCO创新研究奖，成为本届年会最受瞩目的肿瘤临床研究之一，引起现场专家的广泛关注。值得关注的是，该研究此前已入选2026年美国临床肿瘤学会（ASCO）年会最新突破性摘要（Late-Breaking Abstract, LBA），以口头报告形式公布（LBA 9509）[1]，成为今年63项LBA中唯一一项细胞疗法临床研究，也是ASCO历史上全球首个入选LBA的实体瘤细胞疗法临床研究。从ASCO年会的重磅口头报告，到CSCO年会优秀论文一等奖与2026创新研究奖“双奖”加身，这项由中国学者主导、源自中国原创细胞制备工艺的TIL研究，持续获得国际、国内顶级学术舞台的高度认可。正值CSCO年会召开之际，医脉通特邀斯璐教授，对MIZAR-003研究结果进行解读，分享黑色素瘤免疫治疗耐药的诊疗现状与展望。面对黑色素瘤后线治疗困境，细胞疗法带来新曙光中国黑色素瘤的疾病谱与欧美存在显著差异。欧美患者以皮肤型为主，而我国患者中肢端型约占一半，黏膜型约占四分之一，两者合计超过四分之三；相比之下，欧美人群中这两类亚型合计不足5%。这一流行病学特征不仅影响分子分型，也直接关系到免疫治疗的应答。既往研究显示，肢端型和黏膜型黑色素瘤对免疫检查点抑制剂（ICI）的敏感性低于皮肤型。研究显示[2]，中国晚期黑色素瘤患者对PD-1单抗的客观缓解率（ORR）约为17.3%，远不及西方人群。更值得注意的是，对于PD-1单抗治疗失败的患者，尤其是肢端型和黏膜型患者，后线治疗中临床可选方案十分有限，目前化疗的疗效欠佳，亟需新的治疗策略。对此，细胞疗法作为一种新型抗肿瘤手段，在血液肿瘤中取得研究成功后，近些年来逐步在实体瘤中进行探索。而TIL疗法在实体瘤中的尝试，也在黑色素瘤治疗中率先取得亮眼的成绩，有望为免疫治疗耐药黑色素瘤患者带来新治疗策略。全球首个黑色素瘤TIL疗法随机对照研究结果出炉：后线ORR 42.0%，中位PFS 4.3个月 MIZAR-003是一项开放标签、随机对照、多中心的关键Ⅱ期临床试验，于2024年12月启动，由北京大学肿瘤医院郭军教授牵头，在国内25家顶尖肿瘤中心开展，主要研究终点为经独立评审委员会（IRC）按RECIST v1.1评估的无进展生存期（PFS）。研究入组均为PD-1单抗治疗失败的晚期黑色素瘤患者，中位既往系统治疗线数为2线，肢端和黏膜型占比81.8%，中位靶病灶直径之和（SOD）为68.4 mm，89.9%患者发生远处转移，一半以上患者发生≥3个器官转移，其中肝、肺、骨等重要脏器转移者占比66.7%。经随机化分组，试验组和对照组基线特征均衡。这是全球首个针对后线黑色素瘤开展的TIL疗法随机对照临床研究。2024年美国食品药品监督管理局（FDA）批准的首款TIL疗法主要基于单臂研究，而MIZAR-003采用随机对照设计，研究质量更高、证据等级更强、科学性更严谨。研究结果显示，GC101 TIL组中位PFS达4.3个月（95% CI 3.0～5.6），显著优于ICC组的1.6个月（95% CI 1.3～2.7）；HR为0.43（95% CI 0.26～0.68），P=0.0002，意味着接受GC101治疗的患者疾病进展或死亡风险降低57%，主要研究终点顺利达成。总生存期（OS）数据尚未成熟，GC101组中位OS尚未达到；值得注意的是，ICC组有高达57.1%的患者在进展后交叉接受GC101 TIL治疗，在这一交叉治疗的干扰下，GC101组仍显示出生存获益趋势。图1. MIZAR-003研究患者PFS数据在ORR方面，GC101 TIL组高达42.0%（21/50），而ICC组仅6.1%（3/49）。GC101组还有部分患者在长期PR后进一步转化为CR，最长缓解持续时间（DoR）已超过12个月，展现出深度且持久的缓解潜力。与国外历史数据[3]间接对比，在低强度清淋、免IL-2的方案下，GC101在肢端/黏膜为主、多线失败、高肿瘤负荷的更难治人群中取得相当的PFS、甚至更优的ORR，显示出令人鼓舞的疗效信号。图2-3. MIZAR-003研究GC101组和化疗组患者疗效瀑布图药物设计优化：低强度清淋、免IL-2，治疗相关死亡0% 由于传统的TIL细胞对IL-2有依赖性，在体内存活与扩增能力有限，且需清除内源性淋巴细胞竞争、补充细胞因子支持，传统TIL疗法需要高强度清淋化疗并联合大剂量IL-2给药。GC101颠覆了传统TIL疗法的这种固有给药模式，从根源上减少相关不良事件（AE）。这来源于GC101在药物设计与制备工艺上的优化，主要体现在以下方面：第一，优化清淋预处理方案。传统清淋药物如氟达拉滨具有极强的骨髓抑制作用，不仅损伤免疫系统，还会影响TIL细胞生长。GC101采用低强度预处理，并通过免疫调节策略上调肿瘤细胞表面主要组织相容性复合体I类（MHC-I）分子表达，使抗原呈递更加活跃，回输的TIL细胞能更精准地识别抗原并杀伤肿瘤。这不仅降低了清淋毒性，还起到免疫增效作用；第二，革新细胞培养工艺，去除对IL-2的依赖。传统TIL体外培养需加入高浓度IL-2和滋养细胞，导致产出的TIL细胞对IL-2产生巨大依赖，回输后必须补充大剂量IL-2（如60 kg患者单次需约3600万单位），中国患者往往难以耐受多次大剂量输注。GC101在培养过程中将IL-2浓度降至常规的10%左右，并采用由多种细胞因子、抗体和小分子化合物组成的“鸡尾酒”配方进行联合培养。这种工艺不仅使TIL细胞的扩增倍数与传统方法相当，而且产出的TIL细胞表面抑制性分子如PD-1、T细胞免疫球蛋白和黏蛋白结构域分子3（TIM-3）表达明显下降，细胞活性更优。整个生产周期保持在21天左右。从整体安全性结果显示，GC101组不良反应可控，≥3级不良事件主要是预处理导致的血液学毒性。这些不良事件多集中在预处理阶段、呈一过性，中位持续时间仅8天，短于化疗对照组的13天（其中血液学毒性均为9天，非血液学毒性为7天 vs 16天）。相较于既往数据，GC101的安全性表现更加亮眼：未发生治疗相关死亡事件（0% vs 7.5%），无患者出现持续30天以上的≥3级血细胞减少（0% vs 45.5%），红细胞和血小板输注率均低于5%，多数患者无需额外干预即可恢复，实现快速出院。凭借优异的安全性，GC101组未观察到大剂量IL-2相关的毛细血管渗漏综合征、低血压以及发热性中性粒细胞减少等毒性，临床应用不再依赖ICU，住院时间更短、恢复更快，可以覆盖更多医院、满足更多患者的治疗需求。这意味着创新TIL治疗不再必需高规格的特殊医护，临床使用门槛与医疗资源占用将大幅降低，同时也为更广泛的联合疗法奠定基础。从后线到前线，从黑色素瘤到其他实体瘤，期待GC101为更多肿瘤患者带来新治疗方法 GC101采用了低强度清淋、免IL-2的创新方案，在保障优异疗效的前提下大幅降低毒副作用，代表着“下一代TIL疗法”，充分展示了中国在细胞治疗工艺创新上的硬核实力。随着该研究在ASCO年会和CSCO年会的相继报道，并荣膺CSCO优秀论文一等奖与2026创新研究奖，GC101后续有望获得国家药品监督管理局（NMPA）批准上市。当前，2026版CSCO黑色素瘤诊疗指南已将GC101纳入推荐。GC101针对多种实体瘤的一线治疗、辅助治疗也已获批IND，即将开展临床试验。更令人期待的是，GC101的未来不会仅仅局限于黑色素瘤，其他实体瘤的探索也已提上日程，正在开展治疗NSCLC的II期研究。以TIL疗法为代表的细胞免疫治疗，从黑色素瘤出发，未来必将惠及更多实体瘤患者。参考文献 [1]Lu S, et al. A multicenter, randomized, controlled, open-label, phase II trial of autologous tumor-infiltrating lymphocytes (GC101 TIL) in patients with advanced melanoma. 2026 ASCO. LBA 9509. [2]Tang B, et al. Safety, Efficacy, and Biomarker Analysis of Toripalimab in Previously Treated Advanced Melanoma: Results of the POLARIS-01 Multicenter Phase II Trial. Clin Cancer Res. 2020 Aug 15;26(16):4250-4259. [3] Theresa Medina, et al. Long-Term Efficacy and Safety of Lifileucel Tumor-Infiltrating Lymphocyte Cell Therapy in Patients With Advanced Melanoma: A 5-Year Analysis of the C-144-01 Study. J Clin Oncol 43, 3565-3572 (2025). 审校：Leon 排版：Atai 执行：Atai 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。

CSCO会议ASCO会议免疫疗法临床结果临床2期

2026-09-23

·丁香园 Insight 数据库

ESMO LBA 摘要揭晓！近 30 项中国研究入选，全体大会研究独占 4 席

2026 年欧洲肿瘤内科学会（ESMO）年会将于 10 月 23 日至 27 日在西班牙马德里举行。作为全球肿瘤学领域最具影响力的综合性学术会议之一，ESMO 每年汇聚来自世界各地的肿瘤领域顶尖专家学者与临床医生，覆盖从基础研究、机制探索到临床试验与诊疗实践的全链条，是全球肿瘤治疗格局和研究方向的重要学术窗口。当前，ESMO 官网已正式公布了超 90 项 Late-Breaking Abstract（LBA，突破性摘要）标题，其中 12 项最具突破意义及最能改变临床实践的 LBA 研究将在 ESMO 全体大会环节汇报。值得关注的是，近年来中国肿瘤研究的国际影响力持续攀升，越来越多由中国学者牵头或深度参与的研究登上 ESMO 等国际顶级学术会议的重要报告舞台。今年 ESMO 大会上，共有 28 项中国 LBA 研究入选，其中 4 项进入全体大会环节，占比达三分之一。从创新治疗探索到关键临床研究，中国研究者正持续为全球肿瘤学循证证据贡献「中国数据」。一、Presidential Symposium（主席研讨会）摘要号：LBA6 中文标题：奥希替尼联合赛沃替尼对比含铂培美曲塞方案治疗 EGFR 突变伴 MET 过表达和 / 或扩增的奥希替尼进展后晚期 NSCLC：SAFFRON III 期主要结果英文标题：Osimertinib (osi) + savolitinib (savo) vs platinum–pemetrexed (plat–pem) in EGFRm MET-overexpressed (OE) and/or -amplified (AMP) advanced NSCLC post-osi: SAFFRON Phase (Ph) 3 primary results 讲者：上海交通大学医学院附属胸科医院陆舜摘要号：LBA7 中文标题：CLARITY-Gastric 01（CG-01）：一项 sonesitatug vedotin（Sone-Ve）用于二线及以上治疗 CLDN18.2 阳性晚期或转移性胃食管腺癌（GEC） III 期研究英文标题：CLARITY-Gastric 01 (CG-01): a Phase 3 study of sonesitatug vedotin (Sone-Ve) in second or later-line (2L+) advanced or metastatic Claudin 18.2 (CLDN18.2) positive gastroesophageal carcinoma (GEC) 讲者：中山大学肿瘤防治中心徐瑞华摘要号：LBA8 中文标题：依沃西单抗联合化疗对比度伐利尤单抗联合化疗一线治疗晚期胆道癌：一项随机、对照、双盲 III 期研究（HARMONi-GI1）英文标题：Ivonescimab plus chemotherapy versus durvalumab plus chemotheray as first-line treatment for advanced biliary tract cancer: a randomized, controlled, double- blinded, phase 3 trial (HARMONi-GI1) 讲者：复旦大学附属中山医院周俭摘要号：LBA9 中文标题：Risvutatug Rezetecan（Ris-Rez）对比吉西他滨联合多西他赛治疗重度经治的复发 / 难治骨肉瘤：III 期 ARTEMIS-011 研究主要结果英文标题：Risvutatug Rezetecan (Ris-Rez) versus Gemcitabine and Docetaxel (GD) in Heavily Pretreated Patients (pts) with Relapsed or Refractory (R/R) Osteosarcoma: Primary Results from the Phase 3 ARTEMIS-011 Study 讲者：北京大学人民医院谢璐二、优选论文专场（Proffered paper session） 01 乳腺癌摘要号：LBA13 中文标题：瑞康曲妥珠单抗（SHR-A1811）治疗 HER2 低表达晚期乳腺癌：一项随机 III 期研究（HORIZON-Breast06）英文标题：Trastuzumab rezetecan (SHR-A1811) in HER2-low advanced breast cancer (BC): a randomized, phase 3 study (HORIZON-Breast06) 讲者：中国医学科学院肿瘤医院樊英摘要号：LBA50 中文标题：PANKU-Breast01：伦康依隆妥单抗（iza-bren）治疗既往经治的不可切除局部晚期或转移性 HR+/HER2− 乳腺癌的随机 III 期研究英文标题：PANKU-Breast01: Randomized Phase III Study of Izalontamab Brengitecan (iza-bren) in Previously Treated Unresectable Locally Advanced or Metastatic (LA/M) Hormone Receptor-Positive/HER2-negative (HR+/HER2-) Breast Cancer (BC) 讲者：中国医学科学院肿瘤医院兰波摘要号：LBA15 中文标题：Anbenitamab 联合白蛋白结合型多西他赛治疗 HER2 阳性晚期乳腺癌：一项随机 III 期研究英文标题：Anbenitamab plus albumin-bound docetaxel in patients (pts) with HER2-positive advanced breast cancer (BC): A randomized phase III study 讲者：中国医学科学院肿瘤医院徐兵河 02 肺癌摘要号：LBA66 中文标题：芦康沙妥珠单抗（sac-TMT）联合帕博利珠单抗 vs 化疗联合帕博利珠单抗一线治疗 PD-L1 阴性晚期非鳞 NSCLC：随机 III 期 OptiTROP-Lung06 研究英文标题：Sacituzumab tirumotecan (sac-TMT) plus pembrolizumab (P) versus chemotherapy (chemo) plus pembrolizumab (P) as first-line (1L) treatment for PD-L1 negative advanced non-squamous (nsq) NSCLC: randomized phase 3 OptiTROP-Lung06 study 讲者：同济大学附属东方医院周彩存摘要号：LBA67 中文标题：芦康沙妥珠单抗对比含铂化疗治疗 EGFR-TKI 进展后 EGFR 突变 NSCLC 的最终总生存分析：III 期 OptiTROP-Lung04 研究英文标题：Final OS analysis of sacituzumab tirumotecan (sac-TMT) versus platinum-based chemotherapy in EGFR-mutated non-small cell lung cancer (NSCLC) after progression on EGFR-TKI: phase III OptiTROP-Lung04 study 讲者：中山大学肿瘤防治中心张力摘要号：LBA69 中文标题：赛沃替尼或安慰剂联合奥希替尼一线治疗伴 MET 过表达的 EGFR 突变晚期 NSCLC：III 期 SANOVO 研究结果英文标题：Savolitinib or Placebo Combined with Osimertinib in Treatment-Naïve Advanced NSCLC with EGFR Mutation and MET Overexpression: Results from the Phase 3 SANOVO Study 讲者：广东省人民医院吴一龙摘要号：LBA71 中文标题：PANKU-Lung01：伦康依隆妥单抗（iza-bren）治疗三代 EGFR-TKI 进展后 EGFR 突变非鳞 NSCLC 的随机 III 期研究英文标题：PANKU-Lung01: Randomized Phase III Study of Izalontamab Brengitecan (iza-bren) in EGFR-Mutant Non-squamous Non‑Small Cell Lung Cancer (NSCLC) After Progression on a Third Generation EGFR TKI 讲者：中山大学肿瘤防治中心张力摘要号：LBA72 中文标题：Ruzaltatug rezetecan（HER3 靶向 ADC）vs 含铂化疗治疗 EGFR-TKI 进展后 EGFR 突变晚期 NSCLC：III 期 HERON-Lung01 研究中期分析英文标题：Ruzaltatug rezetecan, a HER3-directed ADC, vs platinum-based chemotherapy (PBC) in EGFR-mutated advanced NSCLC progressing after EGFR-TKI: interim analyses (IA) from the phase 3 HERON-Lung01 trial 讲者：广东省人民医院吴一龙摘要号：LBA64 中文标题：特瑞普利单抗联合化疗用于可切除 II 或 III 期 NSCLC 围手术期治疗：III 期 Neotorch 研究最终分析英文标题：Toripalimab plus chemotherapy as perioperative treatment for resectable stage II or III non-small cell lung cancer (NSCLC): Final analysis of the Phase 3 Neotorch study 讲者：上海交通大学医学院附属胸科医院陆舜 03 黑色素瘤摘要号：LBA55 中文标题：自体肿瘤浸润淋巴细胞（GC101 TIL）治疗晚期黑色素瘤：一项随机、开放标签、关键 II 期试验的延长随访英文标题：TAutologous Tumor-Infiltrating Lymphocytes (GC101 TIL) in Advanced Melanoma: Extended Follow‑up of a Randomized, Open-Label, Pivotal Phase II Trial 讲者：北京大学肿瘤医院斯璐 04 头颈癌摘要号：LBA43 中文标题：Tam-Peli vs 化疗治疗重度经治复发 / 转移性鼻咽癌：多中心、随机、开放标签 III 期研究（TAISHAN-301）英文标题：Tam-Peli versus chemotherapy in heavily pretreated recurrent/metastatic nasopharyngeal carcinoma (R/M NPC): a multicenter, randomized, open-label, phase 3 study (TAISHAN-301) 讲者：中山大学肿瘤防治中心洪少东 05 神经内分泌肿瘤摘要号：LBA57 中文标题：Opamtistomig（LBL-024）单药治疗既往 ≥2 线治疗后的晚期肺外神经内分泌癌：新型 PD-L1×4-1BB 双抗的关键注册 IIb 期研究结果英文标题：Opamtistomig (LBL-024) monotherapy in advanced extra-pulmonary neuroendocrine carcinoma (EP-NEC) after ≥2 prior lines of therapies: results from a pivotal, registrational phase IIb study of a novel PD-L1×4-1BB bispecific antibody 讲者：北京大学肿瘤医院陆明三、快速口头报告专场（Rapid oral session） 01 消化道肿瘤摘要号：LBA80 中文标题：Anbenitamab 联合化疗治疗既往经治的 HER2 阳性胃癌或胃食管结合部癌：KC-WISE 研究总生存（OS）更新分析英文标题：Anbenitamab plus chemotherapy for previously treated HER2-positive gastric or gastroesophageal carcinomas (GC/GEJC): Updated overall survival (OS) analysis of KC-WISE 讲者：解放军总医院徐建明摘要号：LBA81 中文标题：LOMAC 随机试验：II–IIIB 期胃癌患者辅助 XELOX 治疗 4 个月与 6 个月疗程的比较英文标题：Four Months of Adjuvant XELOX versus Six Months in Stage II–IIIB Gastric Cancer — The LOMAC Randomized Trial 讲者：复旦大学附属肿瘤医院徐大志摘要号：LBA85 中文标题：HRS-4642 联合化疗 ± 阿得贝利单抗用于 KRAS G12D 突变胰腺癌围手术期治疗：一项 II 期研究初步结果英文标题：HRS-4642 Plus Chemotherapy ± Adebrelimab as Perioperative Therapy in KRAS G12D-Mutant Pancreatic Cancer: Preliminary Results of a Phase 2 Study 讲者：上海交通大学医学院附属瑞金医院沈柏用 02 乳腺癌摘要号：LBA17 中文标题：HER2-PET 成像预测德曲妥珠单抗（T-DXd）在晚期乳腺癌中的疗效：II 期 PREDICT-HER 试验英文标题：HER2-PET imaging to predict trastuzumab deruxtecan (T-DXd) efficacy in advanced breast cancer: The phase II PREDICT-HER trial 讲者：复旦大学附属肿瘤医院金娟摘要号：LBA27 中文标题：APEX-Breast01：TQB2102 vs 化疗治疗 HER2 低表达复发或转移性乳腺癌的随机 III 期研究结果英文标题：APEX-Breast01: TQB2102 versus chemotherapy in HER2-low recurrent or metastatic breast cancer (r/m BC) : Results from a randomized phase 3 study 讲者：中山大学肿瘤防治中心王树森 03 肺癌摘要号：LBA75 中文标题：Deulorlatinib（TGRX-326）vs 克唑替尼治疗 TKI 初治晚期 ALK 阳性 NSCLC：一项 III 期研究英文标题：Deulorlatinib (TGRX‑326) vs crizotinib in TKI-naive advanced ALK+ NSCLC: a phase 3 study 讲者：中山大学肿瘤防治中心张力摘要号：LBA65 中文标题：诱导免疫联合化疗在潜在可切除或不可切除Ⅲ期非小细胞肺癌中的手术转化与生存结局：前瞻性 II 期研究（CTONG 1804 Part 3）的初步结果英文标题：Surgical Conversion and Survival Outcomes After Induction Chemoimmunotherapy in Potentially Resectable or Unresectable Stage III NSCLC: Preliminary Results from the Prospective Phase II Study (CTONG 1804 Part 3) 讲者：广东省人民医院潘燚 04 黑色素瘤摘要号：LBA61 中文标题：维迪西妥单抗治疗 HER2 高表达、局部晚期或转移性乳房外 Paget 病：前瞻性单臂 II 期研究（Formula-10）英文标题：Disitamab Vedotin in locally advanced or metastatic extramammary Paget’s disease with HER2 high expression: a prospective, single-arm phase II trials (Formula-10) 讲者：中山大学肿瘤防治中心谭星亮 05 头颈癌摘要号：LBA47 中文标题：围手术期替雷利珠单抗联合化疗治疗局部晚期可切除口腔鳞癌的前瞻性随机 II 期研究（OPTIMAL 研究）英文标题：A Prospective, Randomized, Phase II Study of Perioperative Tislelizumab with Chemotherapy in Patients with Locally Advanced Resectable Oral Squamous Cell Carcinoma(OPTIMAL study) 讲者：上海交通大学医学院附属第九人民医院何悦 06 探索性免疫疗法摘要号：LBA52 中文标题：个体化新抗原疫苗联合精准关键病灶放疗（CLERT）治疗晚期实体瘤：iNATURE II 期试验更新结果英文标题：Personalized Neoantigen Vaccine Combined with Precision Critical Lesion Radiotherapy (CLERT) in Advanced Solid Tumors: Updated Results from the iNATURE Phase II Trial 讲者：中国香港大学孔凤鸣 07 新兴疗法摘要号：LBA33 中文标题：GFH276 单药治疗既往经治 RAS 突变晚期实体瘤的安全性与疗效英文标题：Safety and efficacy of GFH276 monotherapy in previously treated RAS-mutated advanced solid tumors 讲者：中山大学肿瘤防治中心马翔宇摘要号：LBA34 中文标题：MRG007（ARR-217），一种靶向 CDH17 的依喜替康抗体偶联药物在局部晚期或转移性实体瘤患者中的首次人体研究英文标题：First-in-human study of MRG007 (ARR-217), a CDH17-directed exatecan ADC, in patients with locally advanced or metastatic solid tumors 讲者：北京大学肿瘤医院李健

2026-09-22

·ioncology

ESMO 2026丨LBA重磅发布！头颈肿瘤与黑色素瘤领域最新进展一文纵览！

编者按：2026年欧洲肿瘤内科学会（ESMO）年会将于当地时间10月23日至27日在西班牙马德里举办。本届大会汇聚全球肿瘤领域的顶尖专家与临床研究者，集中呈现各瘤种的前沿研究成果与诊疗突破，为推动全球抗肿瘤事业的发展持续输送循证动力。继大会常规摘要公布之后，本届ESMO的突破性摘要（Late-Breaking Abstract，LBA）名单与口头报告日程已正式发布。头颈肿瘤与黑色素瘤两大领域共有多项重磅研究入选口头报告专场（Proffered Paper Session）与快速口头报告专场（Rapid Oral），其中中国学者主导的多项研究也将在本次大会上亮相。本文整理了该领域口头报告的研究题目与关键信息，带您提前预览本次ESMO大会的部分亮点。黑色素瘤（一） Presidential Symposium I（主席研讨会I）日期：2026年10月24日地点：Alicante Auditorium - Hall 6 时间：16:30 - 18:15 LBA1 INTerpath-001: Phase 3 study of the mRNA-based individualized neoantigen therapy (INT) intismeran autogene (intismeran) plus pembrolizumab (pembro) vs pembro alone for adjuvant treatment of resected stage IIB-IV melanoma (MEL) INTerpath-001 III期研究：mRNA个体化新抗原疗法intismeran autogene联合帕博利珠单抗对比帕博利珠单抗单药辅助治疗已切除IIB-IV期黑色素瘤讲者：Georgina V. Long（澳大利亚）（二）Proffered paper: Melanoma and other skin tumours（口头报告专场：黑色素瘤与其他皮肤肿瘤）日期：2026年10月23日地点：Barcelona Auditorium - Hall 9 时间：16:15 - 17:45 2071O STARBOARD Phase 3: A randomized, double-blind study of first-line (1L) encorafenib (enco), binimetinib (bini), and pembrolizumab (pembro) vs placebo (pbo) and pembro for unresectable locally advanced or metastatic BRAF V600-mutant melanoma STARBOARD III期研究：恩考芬尼+比美替尼+帕博利珠单抗对比安慰剂+帕博利珠单抗一线治疗不可切除局部晚期或转移性BRAF V600突变黑色素瘤的随机双盲研究讲者：Dirk Schadendorf（德国） LBA54 Primary Analysis of HBI-8000-303: A Randomized Phase 3 Trial of Nivolumab plus HBI-8000 or Placebo in Advanced Melanoma HBI-8000-303研究主要分析：纳武利尤单抗联合HBI-8000或安慰剂治疗晚期黑色素瘤的随机III期试验讲者：Nikhil I. Khushalani（美国） 2072O Efficacy and Safety of Lifileucel and Pembrolizumab in Patients with Immune Check Point Inhibitor-Naïve Advanced Melanoma - Final Results from IOV-COM-202 Study IOV-COM-202研究最终结果：Lifileucel联合帕博利珠单抗治疗免疫检查点抑制剂初治晚期黑色素瘤的疗效与安全性讲者：Andrew J. Furness（英国） LBA55 Autologous Tumor-Infiltrating Lymphocytes (GC101 TIL) in Advanced Melanoma: Extended Followup of a Randomized, Open-Label, Pivotal Phase II Trial 自体肿瘤浸润淋巴细胞（GC101 TIL）治疗晚期黑色素瘤：一项随机、开放标签、关键性II期试验的延长随访结果讲者：斯璐教授（北京大学肿瘤医院）（三）Rapid oral: Melanoma and other skin tumours（快速口头报告专场：黑色素瘤与其他皮肤肿瘤）日期：2026 年 10 月 25 日（周日）地点：Granada Auditorium - Hall 4 时间：10:15 - 11:45 2073RO Patritumab Deruxtecan (HER3-DXd) in Melanoma After Anti-PD-(L) 1 Therapy: Primary Analysis From HERTHENA-PanTumor01 HERTHENA-PanTumor01研究主要分析：Patritumab Deruxtecan（HER3-DXd）治疗经抗PD-(L) 1抑制剂治疗后黑色素瘤患者的疗效讲者：Meredith McKean（美国） 2074RO Enfortumab Vedotin (EV) plus Pembrolizumab (P) for Refractory Advanced Melanoma: Primary Results from the PLUG-IN GEM 2301 Trial PLUG-IN GEM 2301试验主要结果：维恩妥尤单抗联合帕博利珠单抗治疗难治性晚期黑色素瘤讲者：Guillermo De Velasco（西班牙） 2075RO Phase 1 dose expansion of a tetravalent CD137/PD-L1 bispecific antibody (FS222) in PD-1 inhibitor-resistant melanoma patients. 四价CD137/PD-L1双特异性抗体（FS222）治疗PD-1抑制剂耐药黑色素瘤患者的I期剂量扩展研究讲者：Guillermo De Velasco（西班牙） 2076RO Three-year distant metastasis-free survival of the phase 3 NADINA trial comparing neoadjuvant nivolumab plus ipilimumab versus adjuvant nivolumab in resectable stage III melanoma NADINA III期研究3年无远处转移生存结果：可切除III期黑色素瘤新辅助纳武利尤单抗+ 伊匹木单抗对比辅助纳武利尤单抗治疗讲者：Sonja Witteveen（荷兰）（四）Rapid oral 2: Basic science and translational research（快速口头报告专场 2：基础科学与转化研究）日期：2026年10月26日地点：Cordoba Auditorium - Hall 4 时间：10:15 - 11:45 4250RO High affinity FcγR3A germline SNP impairs outcome upon anti-PD1 in melanoma 高亲和力FcγR3A胚系单核苷酸多态性对黑色素瘤患者抗PD-1治疗结局的影响讲者：Steven Wijnen（荷兰） 4251RO Humoral immunity against melanocytic differentiation antigens associates with benefit from immune checkpoint blockade in melanoma 抗黑素细胞分化抗原的体液免疫与黑色素瘤患者免疫检查点抑制剂治疗获益的相关性讲者：Lukas Flatz（德国）头颈肿瘤（一）Proffered paper: Head and neck cancer（口头报告专场：头颈肿瘤）日期：2026年10月25日地点：Madrid Auditorium - Hall 4 时间：08:30 - 10:00 LBA42 HexAgon-HN: a phase 2/3 study of the hexavalent OX40 agonist ordastobart (INBRX-106) in combination with pembrolizumab as first-line treatment (1L tx) of PD-L1–high recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC)—phase 2 primary analysis HexAgon-HN研究II期主要分析：六价OX40激动剂 ordastobart（INBRX-106）联合帕博利珠单抗一线治疗PD-L1高表达复发/转移性头颈部鳞状细胞癌的II/III期研究讲者：Jong Chul Park（美国） LBA43 Tam-Peli versus chemotherapy in heavily pretreated recurrent/metastatic nasopharyngeal carcinoma (R/M NPC): a multicenter, randomized, open-label, phase 3 study (TAISHAN-301) TAISHAN-301研究：Tam-Peli对比化疗治疗多线治疗后复发/转移性鼻咽癌的多中心、随机、开放标签III期研究讲者：洪少东教授（中山大学肿瘤防治中心） LBA44 TPF versus a novel regimen of paclitaxel, carboplatin, and oral metronomic chemotherapy as neoadjuvant treatment for technically unresectable oral cancers: multicentric phase III randomized non-inferiority study 多中心III期随机非劣效性研究：TPF方案对比紫杉醇+卡铂+口服节拍化疗新辅助治疗技术上不可切除口腔癌的疗效讲者：Vanita Noronha（印度） LBA45 Quality of life after primary TORS vs IMRT for patients with early-stage oropharyngeal squamous cell carcinoma (QoLATI/DAHANCA34): a multicentre, open-label, randomised phase 2 trial QoLATI/DAHANCA34研究：早期口咽鳞状细胞癌患者接受经口机器人手术对比调强放疗后的生活质量：一项多中心、开放标签、随机II期试验讲者：Hani I. Channir（丹麦） 1535O Comparable Swallowing Function at 12 Months but Divergent Toxicity Profiles with TOS versus DO-IMRT in Early-Stage Oropharyngeal, Supraglottic and Hypopharyngeal Carcinoma: Primary Results of the Phase III EORTC 1420 'Best-of' Trial EORTC 1420"Best-of"III期研究主要结果：早期口咽、声门上及下咽癌患者接受TOS对比DO-IMRT治疗后12个月吞咽功能相当但毒性特征存在差异讲者：Christian Simon（瑞士）（二）Rapid oral: Head and neck cancer（快速口头报告专场：头颈肿瘤）日期：2026年10月25 日地点：Madrid Auditorium - Hall 4 时间：14:45 - 16:15 LBA46 Niraparib and dostarlimab plus radiotherapy (RT) in locally advanced head and neck squamous cell carcinoma (LA-HNSCC) patients (TTCC-2022-01 RADIAN). RADIAN（TTCC-2022-01）研究：尼拉帕利+多塔利单抗联合放疗治疗局部晚期头颈部鳞状细胞癌患者讲者：Marc Oliva（西班牙） 1536RO ctDNA analysis of the phase 3 KEYNOTE-412 trial: pembrolizumab (pembro) or placebo (pbo) + concurrent chemoradiotherapy (CRT) for locally advanced head and neck squamous cell carcinoma (LA HNSCC) KEYNOTE-412 III期研究ctDNA分析：帕博利珠单抗或安慰剂联合同步放化疗治疗局部晚期头颈部鳞状细胞癌讲者：Jean-Pascal Machiels（比利时） 1537RO A single-arm, multi-institutional, phase 2 study of a pembrolizumab-based organ preservation strategy for locally advanced larynx cancers: SMART-KEY (LACOG 0720) SMART-KEY（LACOG 0720）研究：帕博利珠单抗为基础的器官保留策略治疗局部晚期喉癌的单臂、多中心II期研究讲者：Thiago B. Oliveira（巴西） 1539RO Amivantamab + pembrolizumab + carboplatin in first-line recurrent/metastatic head & neck squamous cell cancer (1L R/M HNSCC): Results from the phase 1b/2 OrigAMI-4 study OrigAMI-4研究Ib/II期结果：埃万妥单抗+帕博利珠单抗+卡铂一线治疗复发/转移性头颈部鳞状细胞癌讲者：Paul L. Swiecicki（美国） 1542RO Phase II Study of Izalontamab Brengitecan (iza-bren) Plus Pembrolizumab in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) 伦康依隆妥单抗（iza-bren）联合帕博利珠单抗治疗复发/转移性头颈部鳞状细胞癌的 II 期研究讲者：季冬梅教授（复旦大学附属肿瘤医院） 1540RO A phase II trial of neoadjuvant nivolumab, docetaxel, and cisplatin followed by surgery and radiation therapy for resectable high-grade salivary gland carcinoma 新辅助纳武利尤单抗+多西他赛+顺铂序贯手术及放疗治疗可切除高级别涎腺癌的II期试验讲者：Sehhoon Park（韩国） LBA47 A Prospective, Randomized, Phase II Study of Perioperative Tislelizumab with Chemotherapy in Patients with Locally Advanced Resectable Oral Squamous Cell Carcinoma (OPTIMAL study) OPTIMAL研究：替雷利珠单抗围手术期联合化疗治疗局部晚期可切除口腔鳞状细胞癌的前瞻性、随机II期研究讲者：何悦教授（上海交通大学医学院附属第九人民医院） 1538RO First Interim Safety analysis of GORTEC 2024-03 IDEAL: randomized phase II trial of induction treatment anti–PD-1 pucotenlimab (HX008) plus EGFR-ADC (becotatug vedotin (MRG003) versus EGFR-ADC alone followed by chemoradiotherapy in locally advanced head and neck squamous cell carcinoma GORTEC 2024-03 IDEAL研究首次中期安全性分析：抗PD-1单抗普特利单抗（HX008）联合EGFR-ADC（维贝柯妥塔单抗，MRG003）诱导治疗对比EGFR-ADC单药序贯放化疗治疗局部晚期头颈部鳞状细胞癌的随机II期试验讲者：陶运淦教授（法国） 1541RO Perioperative Cetuximab combined with Toripalimab for Locally Recurrent Resectable Head and Neck Squamous Cell Carcinoma: A Prospective, Single-arm, Phase II Study 围手术期西妥昔单抗联合特瑞普利单抗治疗局部复发可切除头颈部鳞状细胞癌的前瞻性、单臂II期研究讲者：鞠侯雨教授（上海交通大学医学院附属第九人民医院）（来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息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，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床结果临床2期信使RNAASCO会议临床3期

100 项与特瑞普利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D12202	-	L01XC	DB15043

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
HER2阳性尿路上皮癌	中国	上海君实生物医药科技股份有限公司	2026-05-19
转移性黑色素瘤	中国	上海君实生物医药科技股份有限公司	2025-04-22
不可切除的黑色素瘤	中国	上海君实生物医药科技股份有限公司	2025-04-22
晚期肝细胞癌	中国	上海君实生物医药科技股份有限公司	2025-03-18
转移性食管鳞状细胞癌	欧盟	Topalliance Biosciences, Inc.	2024-09-19
转移性食管鳞状细胞癌	冰岛	Topalliance Biosciences, Inc.	2024-09-19
转移性食管鳞状细胞癌	列支敦士登	Topalliance Biosciences, Inc.	2024-09-19
转移性食管鳞状细胞癌	挪威	Topalliance Biosciences, Inc.	2024-09-19
鼻咽肿瘤	欧盟	Topalliance Biosciences, Inc.	2024-09-19
鼻咽肿瘤	冰岛	Topalliance Biosciences, Inc.	2024-09-19
鼻咽肿瘤	列支敦士登	Topalliance Biosciences, Inc.	2024-09-19
鼻咽肿瘤	挪威	Topalliance Biosciences, Inc.	2024-09-19
复发性食管鳞状细胞癌	欧盟	Topalliance Biosciences, Inc.	2024-09-19
复发性食管鳞状细胞癌	冰岛	Topalliance Biosciences, Inc.	2024-09-19
复发性食管鳞状细胞癌	列支敦士登	Topalliance Biosciences, Inc.	2024-09-19
复发性食管鳞状细胞癌	挪威	Topalliance Biosciences, Inc.	2024-09-19
不能切除的食管鳞状细胞癌	欧盟	Topalliance Biosciences, Inc.	2024-09-19
不能切除的食管鳞状细胞癌	冰岛	Topalliance Biosciences, Inc.	2024-09-19
不能切除的食管鳞状细胞癌	列支敦士登	Topalliance Biosciences, Inc.	2024-09-19
不能切除的食管鳞状细胞癌	挪威	Topalliance Biosciences, Inc.	2024-09-19

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
肿瘤	申请上市	加拿大	Apotex, Inc.	2024-12-01
复发性鼻咽癌	申请上市	欧盟	Tmc Pharma (Eu Ltd.	2022-11-14
复发性非鳞状非小细胞肺癌	临床3期	中国	上海君实生物医药科技股份有限公司	2024-04-03
难治性经典霍奇金淋巴瘤	临床3期	中国	上海君实生物医药科技股份有限公司	2023-12-28
局限期小细胞肺癌	临床3期	美国	上海君实生物医药科技股份有限公司	2023-11-15
局限期小细胞肺癌	临床3期	中国	上海君实生物医药科技股份有限公司	2023-11-15
局限期小细胞肺癌	临床3期	荷兰	上海君实生物医药科技股份有限公司	2023-11-15
局限期小细胞肺癌	临床3期	西班牙	上海君实生物医药科技股份有限公司	2023-11-15
局限期小细胞肺癌	临床3期	中国台湾	上海君实生物医药科技股份有限公司	2023-11-15
局限期小细胞肺癌	临床3期	土耳其	上海君实生物医药科技股份有限公司	2023-11-15

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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


WCLC2026	N/A	非小细胞肺癌一线	50	Toripalimab in combination with chemotherapy	願壓繭網願鬱鑰鹹鏇網(夢顧襯願鹽積淵衊艱鬱) = 鬱觸獵衊窪窪積願餘艱繭繭衊膚構膚齋網鑰願 (壓餘衊襯齋繭觸鏇壓齋 ) 更多	积极	2026-09-12
				Toripalimab in combination with chemotherapy (PD-L1 ≥50%)	觸廠構襯醖醖築築憲範(顧繭範構觸範餘選選網) = 壓衊繭製製顧壓願遞獵顧遞願廠淵窪蓋製鹽蓋 (願網鹹淵鹽範繭鹽獵繭 ) 更多
NCT06293690 (WCLC2026)	临床2期	非小细胞肺癌新辅助	20	Lattice SF-SBRT + Toripalimab + Platinum-based Chemotherapy	淵壓製獵鏇艱壓襯艱夢(鹽廠夢願範鬱範製鹽艱) = 齋鹹築淵醖齋衊衊鏇蓋夢鹽顧繭遞廠鹽遞願獵 (簾築鬱積艱觸壓積範構 ) 更多	积极	2026-09-12
NCT03926338 (PICC-2, Pubmed \| Lancet Oncol)	临床2期	错配修复缺陷或微卫星高度不稳定性结直肠癌新辅助 dMMR \| MSI-H	110	Toripalimab plus celecoxib	簾獵鏇醖糧築醖製餘顧(網齋糧獵願壓鬱醖壓襯) = 範築願網積鹹願選鬱積夢鑰鏇顧遞構範醖鏇廠 (蓋選構鹹齋顧衊簾製選, 78 ~ 96) 更多	积极	2026-08-01
				Toripalimab monotherapy	簾獵鏇醖糧築醖製餘顧(網齋糧獵願壓鬱醖壓襯) = 齋繭觸製鏇餘願廠製憲夢鑰鏇顧遞構範醖鏇廠 (蓋選構鹹齋顧衊簾製選, 55 ~ 81) 更多
NCT04158440 (Neotorch, Pubmed \| JAMA Surg)	临床3期	非小细胞肺癌 III期	404	Toripalimab (240 mg) plus platinum-based chemotherapy	齋鏇襯構願壓齋艱獵齋(構觸遞繭簾壓遞憲糧範) = With a median follow-up of 18.3 months, a better EFS was noticed in the toripalimab group. Tumor and lymph node downstaging in the toripalimab group were both associated with better EFS than nondownstaging (median EFS, not estimable [NE] vs 17.5 months; P =.004 and NE vs 19.2 months; P =.001, respectively), and were also associated with even better EFS than tumor and lymph node downstaging in the placebo group (median EFS, NE vs 22.0 months; P =.002 and NE vs NE; P =.009, respectively). 觸壓襯繭齋觸選築鏇衊 (夢廠憲蓋鑰願鹽製鏇衊 ) 更多	积极	2026-07-15
				Placebo plus platinum-based chemotherapy
NCT07353723 (Pubmed \| Front Immunol)	临床2期	扁桃体肿瘤新辅助	20	Nimotuzumab + Toripalimab + Nab-paclitaxel + Carboplatin	網襯簾憲蓋獵衊願憲選(繭艱顧網齋淵窪憲繭齋) = 鑰製齋憲鹹壓窪願鹽觸鑰憲鹹選憲鏇餘鏇鹹遞 (蓋築簾簾網製製築壓壓 ) 更多	积极	2026-07-14
ESMO_GI2026	N/A	食管鳞状细胞癌一线	42	Toripalimab + chemotherapy	壓願夢窪膚襯觸艱艱壓(窪鏇廠製觸襯壓糧鬱獵) = 顧顧製築範廠鬱範願獵糧鹽鬱襯顧積蓋廠範淵 (壓窪淵蓋獵醖鏇製鏇膚 ) 更多	积极	2026-07-02
				Toripalimab + chemotherapy (PD-L1 ≥1%)	壓願夢窪膚襯觸艱艱壓(窪鏇廠製觸襯壓糧鬱獵) = 選鏇簾糧鏇艱齋膚製鹹糧鹽鬱襯顧積蓋廠範淵 (壓窪淵蓋獵醖鏇製鏇膚 ) 更多
ASCO_Breakthrough2026	N/A	晚期食管鳞状细胞癌	30	Toripalimab (PD-L1 ≥1%)	蓋範糧窪糧醖衊鹽網遞(夢網鹽積齋繭選願廠簾) = 繭遞遞淵顧醖夢範簾鹽餘糧鏇簾鬱餘製範餘鹽 (蓋遞繭蓋構簾憲鑰齋鑰 ) 更多	积极	2026-06-25
				Toripalimab (PD-L1 <1%/not done/unknown)	蓋範糧窪糧醖衊鹽網遞(夢網鹽積齋繭選願廠簾) = 遞鑰築鏇夢鹹選選範製餘糧鏇簾鬱餘製範餘鹽 (蓋遞繭蓋構簾憲鑰齋鑰 ) 更多
NCT04475016 (ASCO_Breakthrough2026)	临床2期	阴茎鳞状细胞癌新辅助	29	Toripalimab plus nimotuzumab combined with taxol-based chemotherapy (TNT regimen)	積選範窪鑰網齋壓鹹襯(廠網壓鬱願築觸觸築積) = 糧鹹淵鏇積糧餘餘積獵選鑰製願觸範繭醖餘憲 (選築鬱艱獵觸憲淵鏇襯, 54.1 ~ 88.2) 更多	积极	2026-06-25
				Toripalimab plus nimotuzumab combined with taxol-based chemotherapy (TNT regimen) (non-pCR group)	衊積鑰齋憲獵醖獵構鑰(壓窪齋願範網願簾壓淵) = 製廠蓋襯醖淵網鹹鹹衊願築鹹選鑰膚範築選觸 (鏇鬱鑰繭艱憲醖齋壓窪, 12 ~ NR) 更多
NCT06415318 (ASCO_Breakthrough2026)	临床2期	阴茎鳞状细胞癌巩固 \| 维持 \| 新辅助	25	Toripalimab combined with TIP chemotherapy	願艱鏇艱鏇餘簾醖簾繭(膚蓋膚蓋壓選鏇鹽壓觸) = 鏇襯壓壓窪膚願選範淵觸醖網鬱夢製齋構顧衊 (襯齋淵蓋壓鹹襯壓艱構 ) 更多	积极	2026-06-25
ASCO_Breakthrough2026	N/A	食管鳞状细胞癌新辅助	916	Toripalimab-based regimens	醖繭艱觸淵艱齋壓簾齋(襯糧醖繭壓憲製窪鏇獵) = 鏇艱蓋壓鬱壓鏇艱夢鬱獵築夢鏇積窪憲蓋鏇淵 (淵願顧觸獵遞願壓壓醖 )	积极	2026-06-25
				Camrelizumab-based regimens	醖繭艱觸淵艱齋壓簾齋(襯糧醖繭壓憲製窪鏇獵) = 鹽鹽願遞膚齋願膚膚繭獵築夢鏇積窪憲蓋鏇淵 (淵願顧觸獵遞願壓壓醖 )