Efficacy and safety of camrelizumab, apatinib, and capecitabine combination therapy in advanced biliary tract cancer: a phase 2, nonrandomized, prospective study

• Published in: The oncologist (Dayton, Ohio) Ohio), 2024-11, Vol.29 (11), p.e1565-e1574
• Main Authors: Jing, Chao, Bai, Zhigang, Tong, Kuinan, Yang, Xiaobao, Liu, Kun, Wu, Hongwei, Zhu, Jiegao, Guo, Wei, Zhang, Zhongtao, Deng, Wei
• Format: Article
• Language: English
• Subjects: Adult; Aged; Antibodies, Monoclonal, Humanized - administration & dosage; Antibodies, Monoclonal, Humanized - adverse effects; Antibodies, Monoclonal, Humanized - therapeutic use; Antimitotic agents; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biliary Tract Neoplasms - drug therapy; Biliary Tract Neoplasms - mortality; Biliary Tract Neoplasms - pathology; Cancer; Capecitabine; Capecitabine - administration & dosage; Capecitabine - adverse effects; Capecitabine - therapeutic use; Chemotherapy; Chemotherapy, Combination; Clinical trials; Dosage and administration; Female; Hepatobiliary; Humans; Male; Middle Aged; Monoclonal antibodies; Oncology, Experimental; Prospective Studies; Pyridines - administration & dosage; Pyridines - adverse effects; Pyridines - therapeutic use; Testing
• ISSN: 1083-7159; 1549-490X; 1549-490X
• DOI: 10.1093/oncolo/oyae154

Biliary tract cancer (BTC) is a highly malignant tumor, with limited therapy regimens and short response duration. In this study, we aim to assess the efficacy and safety of the combination of camrelizumab, apatinib, and capecitabine as the first- or second-line treatment in patients with advanced BTC. In this phase 2, nonrandomized, prospective study, eligible patients received camrelizumab (200 mg, d1, Q3W), apatinib (250 mg, qd, d1-d21, Q3W), and capecitabine (1000 mg/m², bid, d1-d14, Q3W) until trial discontinued. The primary endpoint was the objective response rate (ORR). The secondary endpoints were disease control rate, progression-free survival (PFS), overall survival (OS), and safety. From July 2019 to April 2023, we enrolled a total of 28 patients, of whom 14 patients were in the first-line treatment setting and 14 patients were in the second-line setting. At the data cutoff (April 30, 2023), the median follow-up duration was 18.03 months. Eight of 28 patients reached objective response (ORR: 28.57%), with an ORR of 50% and 7.1% for first-line and second-line treatment patients (P = .033). The median PFS was 6.30 months and the median OS was 12.80 months. Grade 3 or 4 adverse events (AEs) occurred in 9 (32.14%) patients, including elevated transaminase, thrombocytopenia, etc. No serious treatment-related AEs or treatment-related deaths occurred. In this trial, the combination of camrelizumab, apatinib, and capecitabine showed promising antitumor activity and manageable toxicity in patients with advanced BTC, especially in the first-line setting. NCT04720131.