NCT04979663

GEMOX Combined With Donafenib and Tislelizumab in Biliary Tract Cancer

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Biliary Tract Carcinoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab	Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab every 3 weeks

Timeline

• Start date: 2020-12-01
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2021-07-28
• Last updated: 2021-08-09

Locations

1 site across 1 country: China