NIPH Clinical Trials Search

UMIN ID: UMIN000001703

Registered date:12/02/2009

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedAdvanced biliary tract cancer
Date of first enrollment2008/10/01
Target sample size62
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Patients receive gemcitabine (1,000 mg/m2, day 1,15) plus S-1 (80 mg/m2, day 1-14) combination therap every 4 weeks. Patients receive gemcitabine (1,000 mg/m2, day 1,8,15) every 4 weeks.


Primary OutcomeTumor response (Response rate, Disease control rate)
Secondary Outcomeprogression-free survival, overall survival, adverse events

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1) 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

Related Information


public contact
Name Takashi Sasaki
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo Japan
Telephone 03-3815-5411
Affiliation JEIBIC Coordinating Office Department of Gastroenterology, Faculty of Medicine, University of Tokyo
scientific contact
Name Hiroyuki Isayama
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo Japan
Telephone 03-3815-5411
Affiliation Faculty of Medicine, University of Tokyo Department of Gastroenterology