Locoregional gemcitabine plus surufatinib and camrelizumab in FGFR2-non-altered intrahepatic cholangiocarcinoma - Clinical efficacy and manageable safety in a phase 2 trial

Sep 29, 2026

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Phase 2 trial results evaluate locoregional gemcitabine combined with camrelizumab and surufatinib for patients with advanced intrahepatic cholangiocarcinoma lacking FGFR2 alterations. Pre-enrollment biopsy excluded FGFR2-altered cases, and 23 eligible patients were treated until progression or intolerable adverse events. Partial responses were observed in 12 patients, yielding an objective response rate of 52.2%. Median PFS was 11.3 months and median OS 20.3 months, with 18 patients experiencing AEs including one grade 3 event. Exploratory analyses linked higher tumor PD-L1 expression with improved response.

LanguageEnglish

CategoryHealthcare

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Pages11

Reading Time28 min

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Summary

Highlights

Authors and Correspondence

In brief

Summary (Trial outcomes)

Introduction

Background of intrahepatic cholangiocarcinoma

Current treatments and unmet need

Targeted therapy and immunotherapy context

Article Locoregional gemcitabine plus surufatinib and camrelizumab in FGFR2-non-altered intrahepatic cholangiocarcinoma Graphical abstract | Screening Process
| | | --- | --- | | Treatment Strategy
Synergistic Antitumor Activity
Gemcitabine
DEB-TACE or HAIC
Every 4-8 weeks Camrelizumab
Intravenous infusion
200 mg (every 3 weeks) Surufatinib
Oral administration
250 mg (every day)
| | | Efficacy and safety
100%
75%
50%

25%
0%
Median PFS 11.3 months
0 6 12 18 24 30
100%

+ + +

75%

50%
25%
0%
0 6 12 18 24 30
Objective response rate: 52.2% Grade 1-2 AE: 17/23, 73.9%; Grade 3 AE: 1/23, 4.3% | | Highlights Authors Bin Guo, Yunhui Fan, Danfeng Li, ..., Shuai Xiang, Enyu Liu, Wanguang Zhang Correspondence [xiangshuai_hust@163.com](xiangshuai_hust@163.com) (S.X.), [liuenyu@163.com](liuenyu@163.com) (E.L.), [wgzhang@tjh.tjmu.edu.cn](wgzhang@tjh.tjmu.edu.cn) (W.Z.) In brief In a phase 2 trial, [Guo et al. report](Guo et al. report) that combining locoregional gemcitabine with camrelizumab and surufatinib demonstrates promising efficacy and manageable safety in intrahepatic cholangiocarcinoma patients without FGFR2 alterations, offering a potential treatment for this population. • The combination therapy is clinically feasible for advanced FGFR2-non-altered ICC • The ORR is 52.2%, and the median OS is 20.3 months • The safety profile is manageable, with only one grade 3 AE observed • Higher tumor PD-L1 expression is associated with improved treatment response Guo et al., 2025, Cell Reports Medicine 6, 102482 December 16, 2025 © 2025 The Authors. Published by Elsevier Inc. [https://doi.org/10.1016/j.xcrm.2025.102482](https://doi.org/10.1016/j.xcrm.2025.102482) ll ll OPEN ACCESS Article Locoregional gemcitabine plus surufatiniband camrelizumab in FGFR2-non-altered intrahepatic cholangiocarcinoma Bin Guo,1,6 Yunhui Fan,1,6 Danfeng Li,1,6 Feng Xia,1,6 Chu Luo,1 Jinghan Zhu,1 Yang Wu,1 Zhiwen Zhu,1 Shuai Xiang,1,* Enyu Liu,2,3,* and Wanguang Zhang1,4,5,7,* 1Division of Hepato-Pancreato-Biliary Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430000, China 2Organ Transplant Department, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, 250012, China 3Department of General Surgery, Qilu Hospital of Shandong University Dezhou hospital, De zhou, 253000, China 4Hubei key Laboratory of Hepao-Pancreato-Biliary Disease, Wuhan, Hubei, China 5Key Laboratory of Organ Transplantation, Ministry of Education, NHC Key Laboratory of Organ Transplantation, Chinese Academy of Medical Sciences, Wuhan, Hubei, China 6These authors contributed equally 7Lead contact *[Correspondence:](Correspondence: xiangshuai_hust@163.com)[ xiangshuai_hust@163.com](Correspondence: xiangshuai_hust@163.com) (S.X.), [liuenyu@163.com](liuenyu@163.com) (E. L.), [wgzhang@tjh.tjmu.edu.cn](wgzhang@tjh.tjmu.edu.cn) (W.Z.) [https://doi.org/10.1016/j.xcrm.2025.102482](https://doi.org/10.1016/j.xcrm.2025.102482) SUMMARY Alterations in fibroblast growth factor receptor 2 (FGFR2) represent potential therapeutic targets in intrahepatic cholangiocarcinoma (ICC), yet they occur in only about 10% of patients. In this study, patients with advanced ICC are tested for FGFR2 alterations via pre-enrollment biopsy; those with alterations are excluded. Eligible patients receive locoregional gemcitabine combined with camrelizumab and surufatinib until disease progression or intolerable adverse events (AEs) . Between July 2022 and June 2024, 23 eligible patients are enrolled. Twelve patients achieve partial response, resulting in an objective response rate of 52.2% . The median progression-free survival is 11.3 months, and the median overall survival is 20.3 months. Eighteen patients experience at least oneAE, including one grade 3 event. Explo

FAQs

What patient population was studied in this phase 2 trial?

Patients with advanced intrahepatic cholangiocarcinoma were screened by pre-enrollment biopsy, and those with FGFR2 alterations were excluded. The study enrolled 23 eligible FGFR2-non-altered patients.

How was the treatment administered in the locoregional combination regimen?

Eligible patients received locoregional gemcitabine combined with camrelizumab and surufatinib, continued until disease progression or intolerable adverse events.

What were the efficacy and survival outcomes reported?

The objective response rate was 52.2%. Median progression-free survival was 11.3 months and median overall survival was 20.3 months.

Sep 29, 2026

Uploaded by Asher