OncoMatch/Clinical Trials/NCT05757336
Combination of Gemcitabine, Albumin-paclitaxel , Sintilimab and Bevacizumab in Unresectable Gallbladder Cancer
Is NCT05757336 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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.
Frequently asked questions
Is NCT05757336 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages