Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab in Unresectable Biliary Tract Cancer
Status:
Recruiting
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
Summary
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.