Camrelizumab plus oxaliplatin-based chemotherapy as first-line therapy for advanced biliary tract cancer: A multicenter, phase 2 trial

被引：48

作者：

Chen, Xinni ^{[1
]}

Qin, Shukui ^{[1
]}

Gu, Shanzhi ^{[2
]}

Ren, Zhenggang ^{[3
]}

Chen, Zhendong ^{[4
]}

Xiong, Jianping ^{[5
]}

Liu, Ying ^{[6
]}

Meng, Zhiqiang ^{[7
]}

Zhang, Xiao ^{[8
]}

Wang, Linna ^{[8
]}

Zhang, Xiaojing ^{[8
]}

Zou, Jianjun ^{[8
]}

机构：

[1] Nanjing Univ Chinese Med, Bayi Affiliated Hosp, Dept Med Oncol Ctr, 34,34 Biao,Yanggongjing St, Nanjing 210002, Jiangsu, Peoples R China

[2] Hunan Canc Hosp, Dept Intervent Radiol, Changsha, Peoples R China

[3] Fudan Univ, Zhongshan Hosp, Liver Canc Inst, Shanghai, Peoples R China

[4] Anhui Med Univ, Hosp 2, Dept Med Oncol, Hefei, Peoples R China

[5] Nanchang Univ, Affiliated Hosp 1, Dept Med Oncol, Nanchang, Jiangxi, Peoples R China

[6] Henan Canc Hosp, Dept Med Oncol, Zhengzhou, Peoples R China

[7] Fudan Univ, Minimally Invas Therapy Ctr, Shanghai Canc Ctr, Shanghai, Peoples R China

[8] Jiangsu Hengrui Pharmaceut Co Ltd, Shanghai, Peoples R China

来源：

INTERNATIONAL JOURNAL OF CANCER | 2021年 / 149卷 / 11期

关键词：

biliary tract cancer; camrelizumab; combination therapy; efficacy; safety; systemic chemotherapy; ADVANCED HEPATOCELLULAR-CARCINOMA; OPEN-LABEL; GEMCITABINE; CHOLANGIOCARCINOMA; CISPLATIN; EXPRESSION;

D O I：

10.1002/ijc.33751

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Biliary tract cancer (BTC) is a highly malignant tumor with limited treatment options and poor prognosis. Our study aimed to evaluate camrelizumab plus oxaliplatin-based chemotherapy as first-line therapy for advanced BTC. In this multicenter, open-label, phase 2 trial conducted in China (, NCT03092895), untreated patients with advanced BTC were given camrelizumab (3 mg/kg iv drip injection, every 2 weeks) plus typical FOLFOX4 (Cam-FOLFOX4 group; infusional 5-fluorouracil, leucovorin and oxaliplatin) or GEMOX (Cam-GEMOX group; infusional gemcitabine and oxaliplatin). The primary endpoint was objective response rate (ORR). Ninety-two patients were enrolled: 29 received Cam-FOLFOX4 and 63 received Cam-GEMOX. The confirmed ORR and disease control rate were 16.3% (95% confidence interval [CI] = 9.4-25.5) and 75.0% (95% CI = 64.9-83.4), respectively. Median duration of response was 8.7 months (95% CI = 5.1-not reached). Median progression-free survival and overall survival were 5.3 months (95% CI = 3.7-5.7) and 12.4 months (95% CI = 8.9-16.1), respectively. Grade >= 3 treatment-related adverse events (TRAEs) occurred in 82.8% of patients receiving Cam-FOLFOX4 and in 68.3% receiving Cam-GEMOX, with no unexpected effects observed. Six (6.5%) patients discontinued treatment due to TRAE. Camrelizumab plus FOLFOX4 or GEMOX as first-line treatment was effective and tolerable for Chinese patients with advanced BTC, warranting phase 3 trials.

引用

页码：1944 / 1954

页数：11

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