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

Abstract

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 (ClinicalTrials.gov, 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.

• Authors: Xinni Chen, Shukui Qin, Shanzhi Gu, Zhenggang Ren, Zhendong Chen, Jianping Xiong, Ying Liu, Zhiqiang Meng, Xiao Zhang, Linna Wang, Xiaojing Zhang, Jianjun Zou
• Journal: International journal of cancer (Int J Cancer) Vol. 149 Issue 11 Pg. 1944-1954 (12 01 2021) ISSN: 1097-0215 [Electronic] United States
• PMID: 34309846 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: © 2021 UICC.

Chemical References

• Antibodies, Monoclonal, Humanized
• Oxaliplatin
• camrelizumab

Topics

• Adult
• Aged
• Antibodies, Monoclonal, Humanized (adverse effects, therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Biliary Tract Neoplasms (drug therapy, pathology)
• China
• Female
• Humans
• Male
• Middle Aged
• Oxaliplatin (adverse effects, therapeutic use)
• Progression-Free Survival
• Safety
• Treatment Outcome