Phase II study of gemcitabine, S-1, leucovorin combination therapy for advanced biliary tract cancer

Phase II study of gemcitabine, S-1, leucovorin combination therapy for advanced biliary tract cancer - Phase II study of GSL combination therapy for advanced biliary tract cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010678

Enrollment

Registered

2013-05-15

Start date

2013-06-01

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

Unresectable or recurrent biliary tract cancer

Interventions

GEM+S-1+LV combination therapy GEM: 1,000mg/m2, day1 S-1: 80mg/day(BSA&lt

1.25/m2) 100mg/day(1.25/m2=&lt

BSA&lt

1.5/m2) 120mg/day(BSA=&gt

1.5/m2), day1-7 LV: 50mg/day, day1-7 repeated every 2 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with unresectable or post-operative recurrent biliary tract cancer 2) Patients with pathologically proven biliary tract cancer 3) Patients with Eastern Chemotherapy Oncology Group(ECOG) performance status of 0-2 4) Patients of age >= 20 years 5) Patients have an ability for a sufficient oral intake 6) Patients have an adequate organ function defined as white cell count >= 3,000/mm3, neutrophil >= 1,500/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, normal echocardiogram 7) Patients who expect to survive more than two months. 8) Written informed consent is required from all patients.

Exclusion criteria

Exclusion criteria: 1) Patients with a previous history of a severe drug hypersensitivity 2) Patients with an active concomitant infection 3) Patients with severe comobidities (cardiovascular disease, renal failure, hepatic failure, digestive ulcer, and gastrointestinal bleeding). 4) Patients with an active pulmonary fibrosis or interstitial pneumonia 5) Patients with severe diahrrea 6) Pregnant, lactating female and patients of reproductive potential who did not use effective contraception 7) Patients with uncontrollable massive pleural effusion or massive ascites 8) Patients with an active concomitant malignancy 9) Inappropriate patients for entry on this study in the judgement of the investigator

Design outcomes

Primary

Measure	Time frame
Progression-free survival	—

Secondary

Measure	Time frame
Overall survival, response rate, adverse events	—

Countries

Japan

Contacts

Public ContactNaminatsu Takahara

The University of Tokyo Hospital Department of Gastroenterology

takaharan-int@h.u-tokyo.ac.jp03-3815-5411

Outcome results

None listed

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