Capecitabine Combined With Lenvatinib and Tislelizumab as Adjuvant Treatment After Resection in Patients With BTC

Phase 2 Completed 65 enrolled Fudan University

NaSingle-groupOpen-labelTreatment

Summary

This is a prospective, open-label, single-center clinical study, to evaluate the efficacy and safety of Capecitabine combined with Lenvatinib and Tislelizumab as adjuvant treatment after resection in patients with biliary tract cancer.

Timeline

Start: 2022-02-24
Primary completion: 2023-12-31
Completion: 2025-12-31

Outcome

Missed primary endpoint

paper Despite not meeting the primary endpoint, continued follow-up and further evaluation are warranted to better define the potential role of this combination regimen. PMID 41578300 ↗

Publications

Feng Y, Zhang N, Zhao YM, Pan Q, Mao AR, Zhu WP, Zhang T, Wang L. Adjuvant tislelizumab, lenvatinib, and capecitabine for resected biliary tract cancer: a prospective phase II trial. BMC Med. 2026 Jan 23;24(1):104. doi: 10.1186/s12916-026-04650-0.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capecitabine	Small molecule	1250 mg/m2	—
Subject	Lenvatinib	Small molecule	8 mg	Oral
Subject	Tislelizumab	Monoclonal antibody	200 mg	Intravenous