Combination of Gemcitabine, Albumin-paclitaxel , Sintilimab and Bevacizumab in Unresectable Gallbladder Cancer

Sponsor
Lu Wang, MD, PhD
Study ID
NCT05757336
Phase
PHASE2
Status
Recruiting
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Conditions

  • Gallbladder Cancer
  • Initially Unresectable
  • the First Line Treatment

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Mar 7, 2023
Start date
Dec 22, 2022
Status verified
Feb 2023
Primary completion
Dec 22, 2024
Completion
Dec 22, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: combined treatment group
    Combination of Gemcitabine, Nab-paclitaxel, Sintilimab and Bevacizumab GC regimen: up to the results of safety run-in stage * Dose A: gemcitabine 1000mg/m2, paclitaxel for injection (albumin-bound) 125mg/m2 iv Q3W * Dose B: gemcitabine 800mg/m2, paclitaxel for injection (albumin-bound) 100mg/m2 iv Q3W Sintilimab: 200mg, iv, d1, q3w Bevacizumab: 7.5mg/kg, d1, q3w

Primary Outcome Measure

objective response rate [ Time Frame: 9 weeks ]

Central Contacts

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