Randomized phase II study of gemcitabine and S-1 combination therapy versus gemcitabine in advanced biliary tract cancer (GS-COMBI). - Randomized phase II study of gemcitabine and S-1 combination therapy versus gemcitabine in advanced biliary tract cancer (GS-COMBI).

Japanese Endoscopist & IVRists group for Biliary Tract Cancer (JEIBIC)0 sites62 target enrollmentFebruary 12, 2009

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Advanced biliary tract cancer
Sponsor: Japanese Endoscopist & IVRists group for Biliary Tract Cancer (JEIBIC)
Enrollment: 62
Status: Completed
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

February 12, 2009

End Date

September 1, 2011

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Japanese Endoscopist & IVRists group for Biliary Tract Cancer (JEIBIC)

•1\) Patients with an active concomitant infection 2\) Patients with digestive ulcer or gastrointestinal bleeding 3\) Patients with an active pulmonary fibrosis or interstitial pneumonia 4\) Patients with an active concomitant malignancy 5\) Pregnant, lactating female and patients of reproductive potential who did not use effective contraception 6\) Patients with a previous history of a severe drug hypersensitivity 7\) Patients receiving anti\-cancer drugs 8\) Patients with uncontrollable massive pleural effusion or massive ascites 9\) Inappropriate patients for entry on this study in the judgement of the investigator