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)
BackgroundAlthough 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 gemcitab...
Saved in:
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2025-07-01
|
| Series: | Frontiers in Oncology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fonc.2025.1584007/full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849254199455383552 |
|---|---|
| author | Ying Yang Ying Yang Qing-Yun Xie Qing-Yun Xie Tao Lv Tao Lv Jiayin Yang Jiayin Yang Hai-Peng Yu Xin Zheng Hui Zhang Chang Liu Hong Wu Hong Wu |
| author_facet | Ying Yang Ying Yang Qing-Yun Xie Qing-Yun Xie Tao Lv Tao Lv Jiayin Yang Jiayin Yang Hai-Peng Yu Xin Zheng Hui Zhang Chang Liu Hong Wu Hong Wu |
| author_sort | Ying Yang |
| collection | DOAJ |
| description | BackgroundAlthough 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.MethodsThis 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).DiscussionThe 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.Ethics and trial registrationThis 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. |
| format | Article |
| id | doaj-art-ff0634ea687a4016914ea0d13fac9df9 |
| institution | Kabale University |
| issn | 2234-943X |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Oncology |
| spelling | doaj-art-ff0634ea687a4016914ea0d13fac9df92025-08-20T03:56:05ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2025-07-011510.3389/fonc.2025.15840071584007Postoperative 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)Ying Yang0Ying Yang1Qing-Yun Xie2Qing-Yun Xie3Tao Lv4Tao Lv5Jiayin Yang6Jiayin Yang7Hai-Peng Yu8Xin Zheng9Hui Zhang10Chang Liu11Hong Wu12Hong Wu13Department of General Surgery, West China Hospital, Sichuan University, Chengdu, ChinaLiver Transplant Center, Transplant Center, West China Hospital, Sichuan University, Chengdu, ChinaDepartment of General Surgery, West China Hospital, Sichuan University, Chengdu, ChinaLiver Transplant Center, Transplant Center, West China Hospital, Sichuan University, Chengdu, ChinaDepartment of General Surgery, West China Hospital, Sichuan University, Chengdu, ChinaLiver Transplant Center, Transplant Center, West China Hospital, Sichuan University, Chengdu, ChinaDepartment of General Surgery, West China Hospital, Sichuan University, Chengdu, ChinaLiver Transplant Center, Transplant Center, West China Hospital, Sichuan University, Chengdu, ChinaDepartment of Interventional Therapy, Tianjin Medical University Cancer Institute and Hospital, Tianjin, ChinaDepartment of Hepatobiliary Surgery, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, Shaanxi, ChinaDepartment of Hepatobiliary Surgery, First Affiliated Hospital of Third Military Medical University (Army Medical University), Chongqing, ChinaDivision of Abdominal Tumor Multimodality Treatment, Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan, ChinaDepartment of General Surgery, West China Hospital, Sichuan University, Chengdu, ChinaLiver Transplant Center, Transplant Center, West China Hospital, Sichuan University, Chengdu, ChinaBackgroundAlthough 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.MethodsThis 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).DiscussionThe 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.Ethics and trial registrationThis 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.https://www.frontiersin.org/articles/10.3389/fonc.2025.1584007/fullintrahepatic cholangiocarcinomaadjuvant therapyhepatic arterial infusion chemotherapyimmunotherapychemotherapyphase 2 study |
| spellingShingle | Ying Yang Ying Yang Qing-Yun Xie Qing-Yun Xie Tao Lv Tao Lv Jiayin Yang Jiayin Yang Hai-Peng Yu Xin Zheng Hui Zhang Chang Liu Hong Wu Hong Wu 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) Frontiers in Oncology intrahepatic cholangiocarcinoma adjuvant therapy hepatic arterial infusion chemotherapy immunotherapy chemotherapy phase 2 study |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| topic | intrahepatic cholangiocarcinoma adjuvant therapy hepatic arterial infusion chemotherapy immunotherapy chemotherapy phase 2 study |
| url | https://www.frontiersin.org/articles/10.3389/fonc.2025.1584007/full |
| work_keys_str_mv | AT yingyang postoperativeadjuvanthepaticarterialinfusionchemotherapywithgemcitabinecisplatinsequentialcapecitabinecombinedwithpdl1inhibitorsinresectedhighriskintrahepaticcholangiocarcinomstudyprotocolforaprospectivemulticentersinglearmphase2trialhgccptrial AT yingyang postoperativeadjuvanthepaticarterialinfusionchemotherapywithgemcitabinecisplatinsequentialcapecitabinecombinedwithpdl1inhibitorsinresectedhighriskintrahepaticcholangiocarcinomstudyprotocolforaprospectivemulticentersinglearmphase2trialhgccptrial AT qingyunxie postoperativeadjuvanthepaticarterialinfusionchemotherapywithgemcitabinecisplatinsequentialcapecitabinecombinedwithpdl1inhibitorsinresectedhighriskintrahepaticcholangiocarcinomstudyprotocolforaprospectivemulticentersinglearmphase2trialhgccptrial AT qingyunxie postoperativeadjuvanthepaticarterialinfusionchemotherapywithgemcitabinecisplatinsequentialcapecitabinecombinedwithpdl1inhibitorsinresectedhighriskintrahepaticcholangiocarcinomstudyprotocolforaprospectivemulticentersinglearmphase2trialhgccptrial AT taolv postoperativeadjuvanthepaticarterialinfusionchemotherapywithgemcitabinecisplatinsequentialcapecitabinecombinedwithpdl1inhibitorsinresectedhighriskintrahepaticcholangiocarcinomstudyprotocolforaprospectivemulticentersinglearmphase2trialhgccptrial AT taolv postoperativeadjuvanthepaticarterialinfusionchemotherapywithgemcitabinecisplatinsequentialcapecitabinecombinedwithpdl1inhibitorsinresectedhighriskintrahepaticcholangiocarcinomstudyprotocolforaprospectivemulticentersinglearmphase2trialhgccptrial AT jiayinyang postoperativeadjuvanthepaticarterialinfusionchemotherapywithgemcitabinecisplatinsequentialcapecitabinecombinedwithpdl1inhibitorsinresectedhighriskintrahepaticcholangiocarcinomstudyprotocolforaprospectivemulticentersinglearmphase2trialhgccptrial AT jiayinyang postoperativeadjuvanthepaticarterialinfusionchemotherapywithgemcitabinecisplatinsequentialcapecitabinecombinedwithpdl1inhibitorsinresectedhighriskintrahepaticcholangiocarcinomstudyprotocolforaprospectivemulticentersinglearmphase2trialhgccptrial AT haipengyu postoperativeadjuvanthepaticarterialinfusionchemotherapywithgemcitabinecisplatinsequentialcapecitabinecombinedwithpdl1inhibitorsinresectedhighriskintrahepaticcholangiocarcinomstudyprotocolforaprospectivemulticentersinglearmphase2trialhgccptrial AT xinzheng postoperativeadjuvanthepaticarterialinfusionchemotherapywithgemcitabinecisplatinsequentialcapecitabinecombinedwithpdl1inhibitorsinresectedhighriskintrahepaticcholangiocarcinomstudyprotocolforaprospectivemulticentersinglearmphase2trialhgccptrial AT huizhang postoperativeadjuvanthepaticarterialinfusionchemotherapywithgemcitabinecisplatinsequentialcapecitabinecombinedwithpdl1inhibitorsinresectedhighriskintrahepaticcholangiocarcinomstudyprotocolforaprospectivemulticentersinglearmphase2trialhgccptrial AT changliu postoperativeadjuvanthepaticarterialinfusionchemotherapywithgemcitabinecisplatinsequentialcapecitabinecombinedwithpdl1inhibitorsinresectedhighriskintrahepaticcholangiocarcinomstudyprotocolforaprospectivemulticentersinglearmphase2trialhgccptrial AT hongwu postoperativeadjuvanthepaticarterialinfusionchemotherapywithgemcitabinecisplatinsequentialcapecitabinecombinedwithpdl1inhibitorsinresectedhighriskintrahepaticcholangiocarcinomstudyprotocolforaprospectivemulticentersinglearmphase2trialhgccptrial AT hongwu postoperativeadjuvanthepaticarterialinfusionchemotherapywithgemcitabinecisplatinsequentialcapecitabinecombinedwithpdl1inhibitorsinresectedhighriskintrahepaticcholangiocarcinomstudyprotocolforaprospectivemulticentersinglearmphase2trialhgccptrial |