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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab every 3 weeks
Fudan University Shanghai Cancer Center
Shanghai, China
RECRUITINGSafety: the incidence of adverse events and serious adverse events
Incidence of adverse events and serious adverse events
Time frame: 3 weeks
Disease control rate
Disease control rate
Time frame: 6 weeks
Overall response rate
Overall response rate
Time frame: 6 weeks
Conversion rate
Conversion rate
Time frame: 6 weeks
Overall survival
Overall survival
Time frame: 6 weeks
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