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更新于：2025-12-12
Adebrelimab
阿得贝利单抗
更新于：2025-12-12
概要
基本信息
原研机构 |
在研机构 |
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2023-02-28), |
最高研发阶段(中国)批准上市 |
特殊审评突破性疗法 (中国)、特殊审批 (中国) |
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结构/序列
Sequence Code 13388064H
来源: *****
Sequence Code 13388069L
来源: *****
关联
364
项与 阿得贝利单抗 相关的临床试验NCT07266025
Adebrelimab Combined With Induction Chemotherapy or SHR-8068 for Mismatch Repair-Deficient/Microsatellite Instability-High (dMMR/MSI-H) Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma：A Randomized, Non-comparative Phase 2 Study
ChiCTR2500113380
An Exploratory Clinical Study of Adebrelimab Combined with Apatinib and Chemotherapy as Neoadjuvant Therapy for Initially Unresectable Stage III Non-Small Cell Lung Cancer
NCT07238569
Multicenter, Prospective Phase III Clinical Trial of EBV-DNA-Guided Adaptive Immunotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma
100 项与 阿得贝利单抗 相关的临床结果
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100 项与 阿得贝利单抗 相关的转化医学
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100 项与 阿得贝利单抗 相关的专利（医药）
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38
项与 阿得贝利单抗 相关的文献（医药）2025-11-01International Journal of Surgery
Neoadjuvant immunochemotherapy with adebrelimab combined with the TP regimen for locally advanced OSCC: early results of a single-arm phase II clinical trial
Article
作者: Wang, Yan ; Li, Wenhao ; Wang, Yuepeng ; Cai, Yongkang ; Guo, Junhong ; Kang, Ziqin ; Fang, Songling ; Huang, Zhiquan ; Zhuang, Xiumei ; Wen, Zuozhen ; Huang, Zixian ; He, Yilin
Background::
This study aimed to investigate the efficacy of a PD-L1 inhibitor combined with chemotherapy in the treatment of locally advanced oral squamous cell carcinoma (OSCC).
Materials and Methods::
This study was designed as a single-arm phase II trial, and a total of 30 patients were enrolled. All patients were pathologically confirmed to have head and neck squamous cell carcinoma. Patients received paclitaxel, carboplatin, and adebrelimab every 3 weeks as a treatment cycle, followed by surgery after three cycles of treatment. The primary endpoint was the postoperative pathological complete response (PCR) rate. The secondary endpoints included the objective response rate (ORR), major pathological response (MPR) rate, 2-year disease-free survival rate, and 2-year and 5-year overall survival rates. This study was conducted without using artificial intelligence (AI) tools in accordance with the TITAN Guidelines 2025.
Results::
Among the 30 patients, 28 completed the full three cycles of immunochemotherapy, with an ORR of 60.7%. One patient dropped out, and one patient (3.3%) experienced grade 3–4 adverse reactions, leading to discontinuation after the first cycle. In the per-protocol population, 10 patients (35.7%) achieved a PCR in both the primary lesion and lymph nodes, whereas 18 patients (64.3%), including those with a PCR, achieved a MPR. Additionally, 20 patients (71.4%) achieved clinical to pathological downstaging. Common adverse reactions included alopecia (30; 100%), fatigue (7; 23.3%), anemia (24; 80%), hyperthyroidism (2; 6.7%), and pruritus (5; 16.7%).
Conclusions::
Preoperative neoadjuvant immunochemotherapy effectively improved the PCR rate in patients with locally advanced OSCC. PD-L1 inhibitors combined with chemotherapy have promising preliminary efficacy in patients with resectable locally advanced OSCC. However, additional follow-up is needed to obtain more comprehensive survival data and further validate these initial observations.
2025-07-01BMJ Open Gastroenterology
Adebrelimab plus capecitabine versus capecitabine monotherapy for adjuvant treatment of high-risk resected cholangiocarcinoma (ACHIEVE): protocol for a phase II, multicentre, randomised controlled trial
Article
作者: Cheng, Yuan ; Li, Xiangcheng ; Li, Changxian ; Zhang, Yaodong
Introduction:
Cholangiocarcinoma (CCA) carries a high risk of recurrence even after curative resection. Capecitabine is standard adjuvant therapy, but recurrence rates remain significant, particularly in high-risk patients. Immunotherapy has shown promise in advanced CCA, prompting investigation into its role in earlier settings.
Methods and analysis:
This multicentre, randomised, open-label phase II trial will compare adjuvant adebrelimab plus capecitabine versus capecitabine alone in patients with high-risk resected CCA. The study is being conducted at four tertiary hospitals in Jiangsu Province, China. Eligible patients will be randomised 1:1. The primary endpoint is 1-year recurrence-free survival rate (1y-RFS rate). Secondary endpoints are overall survival, RFS and safety. Exploratory endpoints are circulating tumour DNA (ctDNA)-based MRD assessment.
Ethics and dissemination:
The study is approved by the Institutional Review Board of Jiangsu Provincial People’s Hospital (2024-SR571). Informed consent will be obtained from all participants. The findings will be published in peer-reviewed journals and presented at scientific conferences.
Trial registration number:
NCT06607276
.
2025-06-01BMJ Open
Clinical study of adebrelimab in combination with apatinib and irinotecan for PD-1 inhibitor-ineffective advanced-stage gastric cancer: study protocol for a single-arm, single-centre, exploratory trial
Article
作者: Xia, Xiang ; Guan, Yujing ; Bai, Long ; Aimaiti, Muerzhate ; Zhang, Hao-yu ; Wang, Shuchang ; Ni, Bo ; Yue, Ben ; Gu, Jiayi ; Liu, Tao ; Zhang, Zizhen ; Zhang, Yeqian
Introduction:
Immunotherapy has revolutionised cancer treatment. Immune checkpoint inhibitors have demonstrated significant efficacy across multiple tumour types, including gastric cancer, where several approved programmed cell death 1/programmed cell death-ligand 1 (PD-1/PD-L1) inhibitors show promising antitumour activity. While PD-L1 expression serves as a predictive biomarker for PD-1 inhibitor response, and PD-L1-positive patients generally show better outcomes, therapeutic resistance remains a challenge. Many initial responders eventually develop resistance, and surprisingly, some PD-L1-positive patients fail to achieve expected response rates, indicating emerging resistance mechanisms in potentially responsive populations. Adebrelimab, a PD-L1 inhibitor, demonstrates mechanistic advantages over PD-1 inhibitors, with clinical studies suggesting promising therapeutic potential. When combined with irinotecan, apatinib has shown efficacy in second-line gastric cancer treatment. This study aims to evaluate the efficacy and safety of combining adebrelimab with apatinib and irinotecan for advanced gastric cancer refractory to PD-1 inhibitors.
Method and analysis:
This single-arm, single-centre exploratory trial will be conducted at Renji Hospital, enrolling 32 patients aged 18–75 years. Eligible patients must have initially achieved partial response, complete response or stable disease with progression-free survival (PFS)≥3 months during prior immunotherapy but subsequently progressive disease on imaging. Treatment will continue until meeting discontinuation criteria. The primary endpoint is objective response rate with Clopper-Pearson 95% CI. Secondary endpoints include disease control rate (95% CI), PFS and overall survival (estimated by Kaplan-Meier method), along with safety assessments.
Ethics and dissemination:
All participants will provide informed consent. The protocol has been approved by the Shanghai Jiaotong University School of Medicine, Renji Hospital Ethics Committee (LY2023-201-C). The results will be disseminated through peer-reviewed manuscripts, reports and presentations.
Trial registration number:
ChiCTR2300077329.
100 项与 阿得贝利单抗 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 广泛期小细胞肺癌 | 中国 | 2023-02-28 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 非小细胞肺癌 | 申请上市 | 中国 | 2025-09-23 | |
| 非小细胞肺癌 | 申请上市 | 中国 | 2025-09-23 | |
| 晚期胆道癌 | 临床3期 | 中国 | 2025-11-01 | |
| 晚期宫颈癌 | 临床3期 | 中国 | 2025-10-17 | |
| 局部晚期宫颈癌 | 临床3期 | 中国 | 2025-10-17 | |
| 局部晚期宫颈癌 | 临床3期 | 中国 | 2025-10-17 | |
| PD-L1阳性三阴性乳腺癌 | 临床3期 | 中国 | 2025-09-01 | |
| 转移性胃食管结合部腺癌 | 临床3期 | 中国 | 2025-08-18 | |
| 肌层浸润性膀胱癌 | 临床3期 | 中国 | 2025-04-25 | |
| 晚期肝细胞癌 | 临床3期 | 中国 | 2024-10-28 |
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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 | 局部晚期胃食管交界处腺癌 新辅助 | 27 | Adebrelimab + DOS | 鏇壓膚鹽顧願廠構鹽夢(憲艱餘餘衊製壓膚築蓋) = 簾鹹獵鑰繭簾築糧築顧 顧衊鹹襯餘繭選願選鹽 (繭鏇製糧積築廠製選膚 ) 更多 | 积极 | 2025-10-17 | |
临床2期 | 11 | Adebrelimab 1200 mg IV Q3W with either famitinib or bevacizumab | 膚簾壓齋壓遞顧願鹽蓋(願餘艱壓積築願鬱簾鬱) = 鏇網構窪窪憲鑰淵鹽簾 艱淵襯膚製鏇壓壓廠構 (鏇繭衊觸遞艱鹽壓獵膚 ) 更多 | 积极 | 2025-10-17 | ||
临床2期 | 局部晚期直肠癌 新辅助 | 19 | 範齋夢齋選顧簾艱網膚(鏇觸艱艱醖鏇繭鏇積憲) = 淵觸觸製願蓋鹹鏇觸願 範衊築艱製獵網鬱觸衊 (鬱獵遞膚廠遞衊鹽糧製 ) 更多 | 积极 | 2025-10-17 | ||
临床2期 | HER2 阴性乳腺癌 HER2-negative | 7 | (HER2-negative breast cancer brain metastasis) | 觸鹽觸製壓憲鏇糧憲廠(窪淵蓋窪醖壓簾憲蓋膚) = 壓淵顧築窪構製壓淵廠 繭網觸廠顧窪範淵鑰鬱 (膚糧鹹蓋壓蓋壓築窪簾 ) 更多 | 积极 | 2025-10-17 | |
临床2期 | 21 | 網廠鹹窪衊蓋蓋網餘襯(憲繭網廠壓艱蓋餘繭醖) = 鹽網簾構壓糧襯艱繭範 鏇鹹簾繭窪網鹽窪簾夢 (構鹹廠鹽醖糧鏇構鏇範 ) 更多 | 积极 | 2025-10-17 | |||
临床2期 | 30 | SBRT+adebrelimab (mCRPC) | 窪製鏇願製觸齋觸淵壓(醖網壓製憲醖鹽繭憲襯) = 廠淵憲願顧繭遞衊餘繭 壓簾蓋憲選製醖齋顧鹽 (廠壓願齋鬱積壓獵襯醖, 34.7 ~ 70.8) 更多 | 积极 | 2025-10-17 | ||
临床2期 | 25 | 蓋構觸鏇鏇鏇獵鏇鬱簾(簾範壓廠壓鑰壓衊顧夢) = 觸鑰夢蓋衊顧夢鬱顧願 糧鏇願廠範艱觸選齋範 (構窪襯餘壓糧襯醖醖夢 ) 更多 | 积极 | 2025-10-17 | |||
临床2期 | 局部晚期宫颈癌 新辅助 | 20 | 膚壓膚鹽簾餘觸齋鬱構(選餘築鬱夢鏇願餘醖艱) = 繭衊蓋夢淵範範繭艱夢 繭醖獵簾鏇壓鏇齋廠憲 (齋積膚蓋餘鏇鬱夢膚蓋 ) 更多 | 积极 | 2025-10-17 | ||
临床2期 | 广泛期小细胞肺癌 一线 | 20 | (safety run-in phase (6 patients)) | 廠鑰簾廠襯艱鬱膚糧餘(襯築餘糧觸壓鹹鹽廠蓋) = 淵膚齋鹽鹹觸衊構窪憲 糧鬱積襯窪範築鬱選鹽 (衊鑰觸鑰築網憲鹹醖齋, 50.4 ~ 95.9) 更多 | 积极 | 2025-10-17 | |
N/A | 局部晚期不可切除癌 新辅助 | 9 | 構廠鹹鑰鏇製廠艱願繭(淵願糧遞網壓夢獵艱衊) = 鹽簾憲構壓獵憲淵鹹構 餘積憲廠壓鬱廠選築廠 (襯顧鹽鏇襯獵遞築糧憲 ) 更多 | 积极 | 2025-09-09 |
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