OncoMatch/Clinical Trials/NCT05757336
Combination of Gemcitabine, Albumin-paclitaxel , Sintilimab and Bevacizumab in Unresectable Gallbladder Cancer
Is NCT05757336 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Combination of Gemcitabine, Nab-paclitaxel, Sintilimab and Bevacizumab for gallbladder cancer.
Treatment: Combination of Gemcitabine, Nab-paclitaxel, Sintilimab and Bevacizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic anti-tumor therapy
No previous systemic anti-tumor therapy (radiotherapy, chemotherapy, targeted or immunotherapy, etc.)
Lab requirements
Blood counts
ANC ≥ 1.5x10^9/L and platelets ≥ 90×10^9/L (no G-CSF in past 14 days); Hemoglobin > 9g/dL (no transfusion or erythropoietin in past 21 days)
Kidney function
Creatinine clearance rate (Cockcroft-Gault) ≥ 50 ml/min
Liver function
Total bilirubin ≤ 3 × ULN; AST and ALT ≤2.5×ULN (≤5×ULN with liver metastases); AKP ≤2.5×ULN
Cardiac function
Myocardial enzyme spectrum within normal range (clinically insignificant abnormalities allowed)
Sufficient organ function, the subject needs to meet the following laboratory indicators: ... see full criteria
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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