METHODS article
Front. Oncol.
Sec. Gastrointestinal Cancers: Hepato Pancreatic Biliary Cancers
Volume 15 - 2025 | doi: 10.3389/fonc.2025.1584007
Postoperative Adjuvant Hepatic Arterial Infusion Chemotherapy With Gemcitabine-Cisplatin Sequential Capecitabine Combined With PDL1 inhibitors in Resected High-risk Intrahepatic Cholangiocarcinom: Study Protocol for A Prospective, multicenter, Single-arm, Phase 2 Trial (HgcCP trial)
Provisionally accepted
- 1West China Hospital, Sichuan University, Chengdu, China
- 2Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, China
- 3Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shanxi, China
- 4Department of Hepatobiliary Surgery, Third Affiliated Hospital of Soochow University, Changzhou, Jiangsu Province, China
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Although capecitabine is recommended for postoperative adjuvant treatment of biliary tract cancers (BTC), no studies have specifically focused on the postoperative adjuvant treatment of intrahepatic cholangiocarcinoma (ICC). In recent years, the combination of PD-L1 inhibitors and gemcitabine-cisplatin (GC) has demonstrated promising results in advanced BTC. The combination of GC, PD-L1 inhibitors, and capecitabine may be a potential adjuvant treatment for ICC. This phase II trial evaluates a novel regimen integrating hepatic arterial infusion chemotherapy (HAIC) with GC, sequential capecitabine, and PD-L1 inhibitors (HgcCP) for high-risk ICC after curative surgery.This multicenter, single-arm trial enrolls ICC patients underwent radical surgery. Participants receive two cycles of HAIC with GC, followed by six cycles of capecitabine and eight cycles of PD-L1 inhibitor therapy. After completion of these therapies, patients will enter a 36-month follow-up period. The primary endpoints are recurrence-free survival (RFS) and safety; secondary endpoints include overall survival (OS) and time to recurrence (TTR).The HgcCP trial aims to establish a safe and effective adjuvant strategy for high-risk ICC after curative surgery, leveraging localized HAIC delivery and systemic immunotherapy. Results may guide future phase III trials.This study has been approved by the Ethics Committee of West China Hospital of Sichuan University (IRB No. 2024-1982). The trial was prospectively registered at Chinese Clinical Trial Registry (http://www.chictr.org.cn, ChiCTR2500097319) on February 17, 2025.
Keywords: intrahepatic cholangiocarcinoma, adjuvant therapy, Hepatic arterial infusion chemotherapy, Immunotherapy, chemotherapy, phase 2 study
Received: 26 Feb 2025; Accepted: 16 Jul 2025.
Copyright: © 2025 Yang, Xie, Lv, Jiayin, Yu, Zheng, Zhang, Liu and Wu. 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: Chang Liu, West China Hospital, Sichuan University, Chengdu, China
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