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ORIGINAL RESEARCH article

Front. Immunol.
Sec. Cancer Immunity and Immunotherapy
Volume 15 - 2024 | doi: 10.3389/fimmu.2024.1449211

Chemotherapy Combined with Regorafenib and Immune Checkpoint Inhibitors as A First-Line Treatment for Patients with Advanced Biliary Tract Cancer: A Single Arm Phase II Trial

Provisionally accepted
Jianwei Liu Jianwei Liu *Bai Shilei Bai Shilei Yanfu Sun Yanfu Sun Lei Hu Lei Hu Ge Ruiliang Ge Ruiliang Feng Xue Feng Xue
  • Eastern Hepatobiliary Surgery Hospital, Shanghai, China

The final, formatted version of the article will be published soon.

    Objective: 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.Results: 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 1year 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 antitumor efficacy without causing serious adverse reactions, and can significantly improve the long-term prognosis.

    Keywords: advanced biliary tract cancer, first-line therapy, targeted therapy, Immunotherapy, chemotherapy, prognosis

    Received: 14 Jun 2024; Accepted: 27 Aug 2024.

    Copyright: © 2024 Liu, Shilei, Sun, Hu, Ruiliang and Xue. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Jianwei Liu, Eastern Hepatobiliary Surgery Hospital, Shanghai, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.