Cryoablation Combined With Sintilimab Plus Lenvatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma

Phase 2 Completed 28 enrolled Fudan University

NaSingle-groupOpen-labelTreatment

Summary

The objective of this study is to evaluate the efficacy and safety of cryoablation combined with Sintilimab plus lenvatinib in patients with advanced intrahepatic Cholangiocarcinoma after progression on first line systemic therapy.

Timeline

Start: 2021-08-24
Primary completion: 2024-03-02
Completion: 2024-03-02

Outcome

Met primary endpoint

paper The objective response rate assessed by Response Evaluation Criteria in Solid Tumors version 1.1 was 75.0% (95% confidence interval (CI): 59-91%), meeting the prespecified primary endpoint. PMID 41176543 ↗

Publications

Gu S, Luo Q, Zhang Y, Qian L, Chen K, Liang F, Hu Y, Zhou R, Wang Y, Liu J, Ning Z, Xu L, Meng Z, Li Y, Wang P. Cryoablation plus sintilimab and lenvatinib in advanced or metastatic intrahepatic cholangiocarcinoma: a phase 2 trial. Nat Cancer. 2026 Jan;7(1):60-79. doi: 10.1038/s43018-025-01058-2. Epub 2025 Nov 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lenvatinib	Small molecule	8 mg	Oral
Subject	Lenvatinib	Small molecule	12 mg	Oral
Subject	Sintilimab	Monoclonal antibody	200 mg	Intravenous