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Somatostatin + Chemotherapy in Advanced Gallbladder Carcinoma

NCT01053390Phase 3

Key facts

Status: Completed
Start: Oct 2009
Primary completion: Dec 2013
Countries: 1
Sponsor: Shanghai Jiao Tong University School of Medicine
Modality: Peptides, Recombinant Proteins and Enzymes

Drugs: somatostatin
Conditions: gallbladder carcinoma

Overview

Phase 3, randomised, open-label trial of somatostatin in gallbladder carcinoma (2 arms), sponsored by Shanghai Jiao Tong University School of Medicine. Primary endpoint: Objective Response Rate at 6 months. Started Oct 2009; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Conventional Regimen
Epirubicin, Cisplatin, Leucovorin, 5-FU
New Regimen
Somatostatin + Epirubicin, Cisplatin, Leucovorin, 5-FU

Endpoints

Primary

Objective Response Rate6 months

Secondary

Progression-Free Survival6 months
Overall Survival6 months
Quality of Life6 months
Adverse Events6 months
Carbohydrate Antigen 19-96 months
Carcinoembryonic Antigen6 months

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