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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001703

Enrollment

Registered

2009-02-12

Start date

2008-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced biliary tract cancer

Interventions

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.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with non-resectable or post-operative recurrent biliary tract cancer 2) Patients with pathologically proven or graphically confirmed biliary tract cancer 3) Patients with no prior therapy except surgery 4) Patients with one or more bidimentionally measurable lesions 5) Patients with Eastern Chemotherapy Oncology Group(ECOG) performance status of 0-2 6) Patients of age >= 20 years 7) Patients have an adequate organ function defined as white cell count >= 3,000/mm3, platelet count >= 100,000/mm3, hemoglobin >= 9g/dl, total bilirubin <= 3 times the upper limit of normal, AST and ALT <= 5 times the upper limit of normal, creatinine <= 1.5 times the upper limit of normal, and creatinine clearance >= 50ml/min. 8) Patients have an ability for a sufficient oral intake 9) Written informed consent is required from all patients.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Tumor response (Response rate, Disease control rate)	—

Secondary

Measure	Time frame
progression-free survival, overall survival, adverse events	—

Countries

Japan

Contacts

Public ContactTakashi Sasaki

JEIBIC Coordinating Office Department of Gastroenterology, Faculty of Medicine, University of Tokyo

sasakit-tky@umin.ac.jp03-3815-5411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026