GEMOX Combined With Donafenib and Tislelizumab in Biliary Tract Cancer

Summary

Study design: Prospective, single-arm, single-center study; Primary endpoint: Safety; Secondary endpoints: Disease control rate, overall response rate, conversion rate, overall survival; Main characteristics of enrolled patients: Patients with initially unresectable biliary tract cancer; Interventions: Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab; Sample size: 10 patients; Treatment until: 1. successfully conversed to resectable disease 2. progressed disease 3. intolerable toxicity 4. patient requests withdrawal Research process: In this study, patients who met the inclusion criteria were evaluated at the end of every 2 circles of treatment (6 weeks), up to surgical treatment or disease progression. Safety evaluation: Evaluate adverse reactions according to CTCAE 4.0; Follow up: 12 months after the last case was enrolled.

Timeline

Start

2020-12-01

Primary completion

2022-06

Completion

2022-06

Drugs

Indications