预约演示
更新于：2026-05-17
Tislelizumab
替雷利珠单抗
更新于：2026-05-17
概要
基本信息
药物类型 单克隆抗体 |
别名 Tirelizumab、Tiselizumab、Tislelizumab (USAN/INN) + [8] |
靶点 |
作用方式 抑制剂 |
作用机制 PD-1抑制剂(细胞程序性死亡-1抑制剂) |
在研适应症 |
非在研适应症 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 中国 (2019-12-26), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)、附条件批准 (中国)、孤儿药 (日本)、特殊审批 (中国) |
登录后查看时间轴
结构/序列
Sequence Code 577079733L
来源: *****
Sequence Code 616719194H
来源: *****
关联
902
项与 替雷利珠单抗 相关的临床试验NCT07469306
Prospective, Randomized, Phase II Trial of Modified Short-Course Radiotherapy Plus CAPOX and Tislelizumab Versus Long-Course Chemoradiotherapy Plus Tislelizumab for Locally Advanced Rectal Cancer
NCT07300891
T Cell Inflamed Gene Expression Profiling Score-guided Anti PD-1 Therapy (Tislelizumab Monotherapy) for Refractory Solid Cancer Patients Unexposed to Immunotherapy
NCT07468071
KontRASt-R: An Open-label, Multi-center, Rollover Study for Participants Who Have Been Previously Enrolled Into a Novartis-sponsored Opnurasib (JDQ443) Study and Are Continuing to Benefit From Opnurasib as a Single Agent or in Combination With Other Study Treatments
100 项与 替雷利珠单抗 相关的临床结果
登录后查看更多信息
100 项与 替雷利珠单抗 相关的转化医学
登录后查看更多信息
100 项与 替雷利珠单抗 相关的专利（医药）
登录后查看更多信息
708
项与 替雷利珠单抗 相关的文献（医药）2026-05-01DRUG RESISTANCE UPDATES
Combination of PD-1 blockade and neoadjuvant chemoradiotherapy benefits pMMR/MSS patients with locally advance rectal cancer: A phase 2 clinical trial
Article
作者: Bai, Zhigang ; Xu, Rui ; Sun, Yi ; Gao, Jiale ; Zhang, Chao ; Han, Jiagang ; Xu, Zhuan ; Zhang, Zhongtao ; Yang, Zhengyang ; Chen, Guangyong ; Deng, Wei ; Li, Ang ; Zheng, Jianyong ; Liu, Gang ; Yao, Hongwei ; Sun, Liting ; Zhang, Jie
For patients with mismatch repair-proficient / microsatellite stable (pMMR/MSS) locally advanced rectal cancer (LARC), the NECTAR (NEoadjuvant Chemoradiotherapy plus immunoTherapy for locally Advanced Rectal cancer) trial reported an encouraging pathological complete response (pCR) rate of 40.0%. Given that pMMR/MSS tumors are generally resistant to immunotherapy, this pCR rate highlights the potential of combination therapy to overcome primary resistance. Here, we report the 3-year survival outcomes of the NECTAR trial, using neoadjuvant chemoradiotherapy (NCRT) plus tislelizumab in pMMR/MSS LARC. In this phase 2, multi-center, single-arm trial, eligible pMMR/MSS LARC patients received three cycles of neoadjuvant programmed cell death protein 1 (PD-1) blockade, three cycles of chemotherapy, and long-course radiotherapy followed by total mesorectal excision (TME). This 3-year analysis evaluates disease-free survival (DFS) and safety. From June 2021 to November 2022, 50 patients were enrolled and 46 patients completed neoadjuvant therapy and TME. Of the 46 patients, 20 patients reached pCR. With a median follow-up of 44.2 months, the median DFS was not reached. The 3-year DFS rate was 89.1%. All patients who achieved pCR (20/46) remained DFS at 3 years. Patients with a low neoadjuvant rectal (NAR) score (<8) had the 3-year DFS rate of 100%, suggesting that overcoming therapeutic resistance in immunotherapy may translate into sustained survival benefits. No new grade ≥III treatment-related adverse events (trAEs) occurred during the 3-year follow-up. The 3-year survival outcomes demonstrate promising efficacy and safety of this NECTAR trial, which provides a promising therapeutic avenue for a patient population traditionally resistant to single-agent immunotherapy.
2026-04-18Beijing da xue xue bao. Yi xue ban = Journal of Peking University. Health sciences
[Conversion therapy for hepatoid adenocarcinoma of the stomach: A case report].
Article
作者: Li, Jialin ; Wu, Yan ; Tang, Jiatian ; Wang, Anqiang ; Chen, Liqiao
Hepatoid adenocarcinoma of the stomach (HAS) is a rare and highly malignant variant of gastric cancer, distinguished by histological features resembling hepatocellular carcinoma and frequent elevation of serum alpha-fetoprotein (AFP). It demonstrates aggressive biological behavior, early metasta-tic potential, and intrinsic resistance to conventional platinum-based chemotherapy, resulting in poor outcomes. No standard systemic therapy exists for initially unresectable HAS, making conversion strategies a critical therapeutic goal. We present a 56-year-old male with biopsy-proven locally advanced HAS and markedly elevated AFP (1 729.53 μg/L). Imaging revealed bulky lymphadenopathy (largest node: 39 mm×27 mm), rendering the tumor unresectable. Molecular profiling confirmed human epidermal growth factor receptor 2 (HER2) amplification. First-line conversion therapy with oxaliplatin, fluoropyrimidine, sintilimab (a programmed death-1 inhibitor), and later trastuzumab yielded only transient stabilization followed by clear progression: After six cycles, AFP rose to 1 546.07 μg/L and target lymph nodes enlarged to 46 mm×31 mm on CT. Given treatment failure and persistent HER2 positivity, a second-line, biology-informed regimen was initiated: Disitamab vedotin (an HER2-targeted antibody-drug conjugate delivering monomethyl auristatin E), lenvatinib (a multi-targeted tyrosine kinase inhibitor blocking vascular endothelial growth factor receptor and other pro-angiogenic pathways), tislelizumab (a programmed death-1 inhibitor), and short-course capecitabine (discontinued after 7 days due to grade 3 thrombocytopenia). This combination produced rapid and sustained antitumor activity. Serum AFP declined drama-tically to 102.3 μg/L after two cycles. Radiological reassessment showed progressive shrinkage of metastatic lymph nodes (from 46 mm to 25 mm after cycle two, and further to 14 mm after cycle three) consistent with partial response according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Fluorine-18 fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET-CT) confirmed reduced metabolic activity in residual lesions. These results enabled successful R0 radical distal gastrectomy in June 2024. Final pathology revealed minimal residual disease (ypT1bN1) with hepatoid morphology and positive immunostaining for AFP, glypican-3, Sal-like protein 4, and HER2 (2 +). The patient received two adjuvant cycles of the same targeted-immunotherapy backbone before transitioning to observation due to cumulative toxicity. Eighteen months postoperatively, he remained free of recurrence. This case underscores that in HER2-positive, chemotherapy-refractory HAS, a rationally designed, multimodal regimen integrating an HER2-directed antibody-drug conjugate, antiangiogenic agent, and immune checkpoint blockade can overcome therapeutic resistance, achieve meaningful downstaging, and enable long-term disease control. Early molecular characterization and aggressive, persona-lized intervention are essential for improving outcomes in this rare malignancy.
2026-04-09Future Oncology
The safety and efficacy of recombinant human adenovirus 5 injection (H101) intraperitoneal administration combined with tislelizumab and platinum, fluorouracil-based drugs in the treatment of gastric cancer with peritoneal metastasis: an open-label, single-arm, prospective clinical study protocol
Article
作者: Xia, Xiang ; Zhang, Puhua ; Ni, Bo ; Bai, Long ; Chen, Yiwen ; Zhang, Haoyu ; Dong, Zhongyi ; Liu, Tao ; Shen, Xiaoyao ; Zong, Jiasheng ; Zhang, Zizhen ; Guan, Yujing
This prospective, open-label, single-arm, exploratory clinical trial aims to evaluate the safety and efficacy of intraperitoneal perfusion of recombinant human adenovirus type 5 (H101) in combination with systemic tislelizumab and platinum-fluorouracil chemotherapy (XELOX) for patients with gastric adenocarcinoma and peritoneal metastasis. A total of 20 eligible patients, with or without ascites, will be enrolled to receive intraperitoneal H101 followed by systemic tislelizumab (200 mg, Q3W) and the XELOX regimen (oxaliplatin and capecitabine). The co-primary endpoints are the safety profile and the 1-year overall survival (OS) rate, with an efficacy target of approximately 70%. Secondary endpoints include progression-free survival (PFS), radiological response per RECIST 1.1, and changes in ascites volume and Peritoneal Carcinomatosis Index (PCI). As this is a study protocol, clinical results will be reported upon trial completion. If this triple-combination regimen demonstrates acceptable safety and a promising OS rate, it will provide preliminary evidence to support the further development of this multimodal approach for a high-risk population with limited therapeutic options.Clinical trial registration: chiCTR2500107607.
100 项与 替雷利珠单抗 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 食管癌 | 日本 | 2025-03-27 | |
| PD-L1阳性食管鳞状细胞癌 | 美国 | 2025-03-03 | |
| 局部进展期胃腺癌 | 欧盟 | 2024-12-19 | |
| 局部进展期胃腺癌 | 冰岛 | 2024-12-19 | |
| 局部进展期胃腺癌 | 列支敦士登 | 2024-12-19 | |
| 局部进展期胃腺癌 | 挪威 | 2024-12-19 | |
| 局部晚期胃食管交界处腺癌 | 欧盟 | 2024-12-19 | |
| 局部晚期胃食管交界处腺癌 | 冰岛 | 2024-12-19 | |
| 局部晚期胃食管交界处腺癌 | 列支敦士登 | 2024-12-19 | |
| 局部晚期胃食管交界处腺癌 | 挪威 | 2024-12-19 | |
| 转移性胃腺癌 | 欧盟 | 2024-12-19 | |
| 转移性胃腺癌 | 冰岛 | 2024-12-19 | |
| 转移性胃腺癌 | 列支敦士登 | 2024-12-19 | |
| 转移性胃腺癌 | 挪威 | 2024-12-19 | |
| 转移性胃食管结合部腺癌 | 欧盟 | 2024-12-19 | |
| 转移性胃食管结合部腺癌 | 冰岛 | 2024-12-19 | |
| 转移性胃食管结合部腺癌 | 列支敦士登 | 2024-12-19 | |
| 转移性胃食管结合部腺癌 | 挪威 | 2024-12-19 | |
| 可切除非小细胞肺癌 | 中国 | 2024-10-16 | |
| 广泛期小细胞肺癌 | 中国 | 2024-06-25 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| HER2阳性食管腺癌 | 申请上市 | 美国 | 2026-04-29 | |
| HER2阳性胃食管交界处癌 | 申请上市 | 美国 | 2026-04-29 | |
| HER2阳性胃癌 | 申请上市 | 美国 | 2026-04-29 | |
| HER2阳性胃腺癌 | 申请上市 | 中国 | 2026-04-14 | |
| HER2阳性胃腺癌 | 申请上市 | 中国 | 2026-04-14 | |
| 胃腺癌 | 申请上市 | 欧盟 | 2024-10-17 | |
| 鳞状细胞癌 | 申请上市 | 中国 | 2018-09-06 | |
| 晚期胃食管交界处腺癌 | 临床3期 | 中国 | 2026-01-01 | |
| HER2表达胃食管交界处腺癌 | 临床3期 | 中国 | 2026-01-01 | |
| 结直肠癌 | 临床3期 | 法国 | 2025-04-16 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 肝细胞癌 一线 | 94 | 壓衊顧選壓壓築餘範製(遞簾齋蓋蓋積選糧廠鹹) = 齋窪膚積鹽衊構壓鹹鬱 願網齋鹹膚鹽構鹹艱襯 (遞蓋壓膚獵網鏇築網廠, 25.2 ~ 50.3) 更多 | 积极 | 2026-04-28 | ||
壓衊顧選壓壓築餘範製(遞簾齋蓋蓋積選糧廠鹹) = 鬱艱鏇壓鏇糧夢淵構鹹 願網齋鹹膚鹽構鹹艱襯 (遞蓋壓膚獵網鏇築網廠, 23.7 ~ 59.4) 更多 | |||||||
临床2期 | 160 | 願鑰繭膚選鏇醖衊窪鏇(鏇廠製鬱淵廠憲餘醖構) = 憲鏇獵淵艱壓繭襯簾艱 糧鏇鹽築獵築窪鏇簾壓 (齋鬱廠餘積獵積範膚鏇, 14.6 ~ 43.9) 更多 | 不佳 | 2026-04-18 | |||
願鑰繭膚選鏇醖衊窪鏇(鏇廠製鬱淵廠憲餘醖構) = 鏇鏇網範衊築範鬱網顧 糧鏇鹽築獵築窪鏇簾壓 (齋鬱廠餘積獵積範膚鏇, 14.6 ~ 43.9) 更多 | |||||||
临床3期 | 370 | (Tislelizumab + Chemoradiotherapy) | 製膚製選廠選蓋遞積蓋(選蓋壓憲鑰簾衊築範膚) = 鬱齋淵淵製鑰膚憲獵膚 選願鹹鑰選繭糧窪鏇顧 (襯範壓鹹築蓋顧遞鏇築, 餘鑰鬱糧餘夢製鏇醖鑰 ~ 構壓繭窪憲廠窪襯顧鏇) 更多 | - | 2026-04-13 | ||
(Placebo + Chemoradiotherapy) | 製膚製選廠選蓋遞積蓋(選蓋壓憲鑰簾衊築範膚) = 蓋獵壓鏇鹽鬱壓齋積遞 選願鹹鑰選繭糧窪鏇顧 (襯範壓鹹築蓋顧遞鏇築, 齋糧鹹繭襯鏇繭艱鬱餘 ~ 蓋襯淵積選鏇衊鹽製齋) 更多 | ||||||
临床2期 | 114 | Tislelizumab + Induction Chemotherapy + Concurrent Chemoradiotherapy | 鹽醖願構範遞簾範蓋繭(製繭觸淵衊獵積廠鏇壓): HR = 0.54 (95.0% CI, 0.32 ~ 0.94) 更多 | 积极 | 2026-04-10 | ||
Tislelizumab + Induction Chemotherapy + Concurrent Chemoradiotherapy | |||||||
临床3期 | 鼻咽肿瘤 一线 | 263 | Tislelizumab plus chemotherapy | 糧積襯壓鏇餘餘襯齋襯(淵淵築鬱繭窪醖繭鑰夢) = 鹽獵艱網網範醖艱壓構 積夢願製衊選衊範壓鏇 (遞襯夢憲網膚衊鏇積簾, 7.6 ~ 11.6) 更多 | 积极 | 2026-04-01 | |
Placebo plus chemotherapy | 糧積襯壓鏇餘餘襯齋襯(淵淵築鬱繭窪醖繭鑰夢) = 糧夢觸憲鏇壓膚顧鏇觸 積夢願製衊選衊範壓鏇 (遞襯夢憲網膚衊鏇積簾, 5.6 ~ 7.6) 更多 | ||||||
临床2期 | 30 | Bronchial Arterial Chemoembolization (BACE) + Tislelizumab | 醖衊製憲齋鏇網顧鬱構(蓋築醖觸簾壓夢網獵壓) = 網齋壓憲積餘範願艱廠 艱遞膚衊積鹽餘鏇窪淵 (鏇夢壓顧膚範簾簾憲積 ) 更多 | 积极 | 2026-04-01 | ||
临床2期 | 非小细胞肺癌 新辅助 | 46 | 夢壓鹽齋鹹繭襯網鑰觸(遞鏇衊醖蓋積蓋鹹憲簾) = 獵淵簾築壓淵壓憲夢窪 網築鏇網網遞淵蓋壓膚 (顧夢壓獵憲膚膚選廠遞, 51.6 ~ 78.5) 更多 | 积极 | 2026-03-25 | ||
临床3期 | 广泛期小细胞肺癌 一线 | 457 | Tislelizumab plus chemotherapy | 齋顧衊衊齋艱壓衊鬱製(憲廠廠餘遞壓築糧鑰繭) = The most frequently reported treatment-related adverse events in the tislelizumab and placebo arms were alopecia (78.4% versus 79.5%), anemia (76.7% versus 78.6%), and neutropenia (68.7% versus 70.3%). 願艱鏇製簾觸獵窪顧顧 (襯窪淵廠選鑰襯網繭築 ) 更多 | 积极 | 2026-03-01 | |
Placebo plus chemotherapy | |||||||
临床2期 | 新辅助 HER-2 expressing | 10 | 簾餘餘衊鏇範膚構鬱糧(壓願築艱簾糧餘壓選壓) = 淵襯網憲衊窪鹹艱網製 夢網憲築醖淵鹹襯夢選 (糧鏇窪憲衊繭壓積積繭 ) 更多 | 积极 | 2026-02-26 | ||
临床2期 | 106 | 願範鏇壓夢願衊衊簾鬱(衊襯蓋構襯網鹹齋廠築) = 鹽築顧餘範範蓋憲廠糧 築廠夢獵夢鏇製積願憲 (餘範夢艱壓窪觸鹽製顧 ) | 积极 | 2026-02-26 | |||
願範鏇壓夢願衊衊簾鬱(衊襯蓋構襯網鹹齋廠築) = 艱糧繭憲選願窪餘窪餘 築廠夢獵夢鏇製積願憲 (餘範夢艱壓窪觸鹽製顧 ) 更多 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
生物类似药
生物类似药在不同国家/地区的竞争态势。请注意临床1/2期并入临床2期，临床2/3期并入临床3期
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用