Combination of Gemcitabine, Albumin-paclitaxel , Sintilimab and Bevacizumab in Unresectable Gallbladder Cancer
Status:
Recruiting
Trial end date:
2026-12-22
Target enrollment:
Participant gender:
Summary
Study design: Prospective, single-arm, single-center phase II clinical study; Primary
endpoint: Objective response rate via investigator, Safety; Secondary endpoints: disease
control rate, disease-free survival, overall survival, and proportion of acceptable radical
resection of primary lesions; Main characteristics of enrolled patients: Patients with
initially unresectable gallbladder cancer; Interventions: Combination of Gemcitabine,
Nab-paclitaxel, Sintilimab and Bevacizumab; Sample size: Using Simon's two-stage design, 15
patients in the first stage, and if more than 4pts response, enlarge the sample size to 45
patients in total; 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 9
weeks of treatment, up to surgical treatment or disease progression; Safety evaluation:
Evaluate adverse reactions according to CTCAE 5.0; Follow up: every 90 days (±7 days) until
the subject died, lost follow-up or the end of the study.