Study design: Prospective, single-arm, single-center phase II clinical study; Primary endpoint: Conversion rate; Secondary endpoints: Safety, disease control rate, disease-free survival, and overall survival; Main characteristics of enrolled patients: Patients with initially unresectable biliary tract cancer; Interventions: Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab; Sample size: 34 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 3 weeks of treatment, 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
37
Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab
Fudan University Shanghai Cancer Center
Shanghai, China
objective response rate
objective response rate
Time frame: 3 weeks
Safety: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: 3 weeks
progress-free survival
progress-free survival
Time frame: 3 weeks
overall survival
overall survival
Time frame: 3 weeks
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