Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Gallbladder Neoplasms

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Biliary Tract Diseases

Gastrointestinal Diseases

Gallbladder Diseases

Gallbladder Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Bevacizumab

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

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Antimetabolites

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

Combination of Gemcitabine, Nab-paclitaxel, Sintilimab and Bevacizumab

Lu Wang

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.

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

Explore the Efficacy and Safety of Sintilimab Plus Bevacizumab Combined With Gemcitabine and Albumin-paclitaxel (AG Regimen) in First-line Treatment of Initial Unresectable Gallbladder Cancer: a Phase II Clinical Study

Incidence of adverse events and serious adverse events

Proportion of acceptable radical resection of primary lesions

Lu Wang, MD, PhD

Head of liver surgery department

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Combination of Gemcitabine, Albumin-paclitaxel , Sintilimab and Bevacizumab in Unresectable Gallbladder Cancer	NCT05757336	Gallbladder Can... Initially Unres... the First Line ...	Combination of ...	18 Years - 75 Years	Fudan University
Combination of Gemcitabine, Albumin-paclitaxel , Sintilimab and Bevacizumab in Unresectable Gallbladder Cancer	NCT05757336	Gallbladder Can... Initially Unres... the First Line ...	Combination of ...	18 Years - 75 Years	Fudan University

Spots Global Cancer Trial Database for the first line treatment