Department of Hepatic Surgery II, Third Affiliated Hospital of Naval Medical University (Eastern Hepatobiliary Surgery Hospital), Shanghai, China.
Department of Hepatic Surgery I, Third Affiliated Hospital of Naval Medical University (Eastern Hepatobiliary Surgery Hospital), Shanghai, China.
Front Immunol. 2024 Sep 18;15:1449211. doi: 10.3389/fimmu.2024.1449211. eCollection 2024.
This study aimed to investigate the efficacy, long-term prognosis and safety of combining chemotherapy with regorafenib and immune checkpoint inhibitors as first-line treatment for patients with advanced biliary tract carcinoma (BTC).
In this single arm phase II trial, twenty-nine patients with advanced BTC were included, all of whom received gemcitabine-based chemotherapy combined with regorafenib and immune checkpoint inhibitors as the first-line treatment. And the study analyzed anti-tumor efficacy, long-term prognosis, and adverse reactions.
Among the patients, 0 patient achieved complete response, 18 patients (62.1%) achieved partial response, 8 patients (27.6%) had stable disease, and 3 patients (10.3%) experienced progressive disease. The corresponding objective response rate (ORR) was 18/29 (62.1%), and the disease control rate (DCR) was 26/29 (89.7%). The median overall survival (OS) was 16.9 months (95% confidence interval [CI]: 12.0 -21.8) and the median progress free survival (PFS) was 10.2 months (95% CI: 7.8- 12.6). The 1-year OS and PFS were 65% (95% CI: 0.479-0.864) and 41% (95% CI: 0.234-0.656), respectively. The incidence of adverse reactions was 27/29 (93.1%), and the incidence of grade III/IV adverse reactions was 5/29 (17.2%).
The combination of chemotherapy, regorafenib, and immune checkpoint inhibitors as a first-line treatment for patients with advanced BTC may has good anti-tumor efficacy without causing serious adverse reactions, and can significantly improve the long-term prognosis.
本研究旨在探讨化疗联合regorafenib 和免疫检查点抑制剂作为晚期胆道癌（BTC）一线治疗的疗效、长期预后和安全性。
在这项单臂 II 期临床试验中，纳入了 29 例晚期 BTC 患者，所有患者均接受吉西他滨为基础的化疗联合 regorafenib 和免疫检查点抑制剂作为一线治疗。并对研究分析抗肿瘤疗效、长期预后和不良反应。
患者中，0 例完全缓解，18 例（62.1%）部分缓解，8 例（27.6%）病情稳定，3 例（10.3%）疾病进展。相应的客观缓解率（ORR）为 18/29（62.1%），疾病控制率（DCR）为 26/29（89.7%）。中位总生存期（OS）为 16.9 个月（95%置信区间 [CI]：12.0-21.8），中位无进展生存期（PFS）为 10.2 个月（95%CI：7.8-12.6）。1 年 OS 和 PFS 分别为 65%（95%CI：0.479-0.864）和 41%（95%CI：0.234-0.656）。不良反应发生率为 27/29（93.1%），III/IV 级不良反应发生率为 5/29（17.2%）。
化疗、regorafenib 和免疫检查点抑制剂联合作为晚期 BTC 患者的一线治疗可能具有良好的抗肿瘤疗效，且不会引起严重不良反应，可显著改善长期预后。
