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GEMOX Combined With Donafenib and Tislelizumab in Biliary Tract Cancer

Biliary Tract Carcinoma Clinical Trial

Official title:
Safety and Efficacy of GEMOX Combined With Donafenib and Tislelizumab as First-line Treatment in Biliary Tract Cancer

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04979663
Study type Interventional
Source Fudan University
Contact Lu Wang, M.D.
Phone +86-18121299357
Email w.lr@hotmail.com
Status Recruiting
Phase Phase 1/Phase 2
Start date December 1, 2020
Completion date June 2022
View Details
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