Gemcitabine and cisplatin combination chemotherapy for patients with unresectable advanced and recurrent biliary tract cancer

Gemcitabine and cisplatin combination chemotherapy for patients with unresectable advanced and recurrent biliary tract cancer - Gemcitabine and cisplatin combination chemotherapy for patients with unresectable advanced and recurrent biliary tract cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007571

Enrollment

Registered

2012-03-30

Start date

2008-08-01

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 and recurrent biliary tract cancer

Interventions

Gemcitabine 1000mg/m2 is administered as 30min intravenous infusion and cisplatin 20mg/m2 is administered as 120min intravenous infusion on day1 and day8. The cycle is repeated every 3 weeks until dis

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with non-resectable or post-operative recurrent biliary tract cancer including intrahepatic cholangiocarcinoma 2) Patients with pathologically proven or graphically confirmed biliary tract cancer 3) Patients with advanced biliary tract cancer refractory to gemcitabine and S-1. 4) Patients with Eastern Chemotherapy Oncology Group(ECOG) performance status of 0-2 5) Patients of age >= 20 years 6) 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. 7) 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 severe cardiovascular or renal disease 4) Patients with an active pulmonary fibrosis or interstitial pneumonia 5) Patients with uncontrollable massive pleural effusion or massive ascites 6) Patients with an active concomitant malignancy 7) Pregnant, lactating female and patients of reproductive potential who did not use effective contraception 8) Patients with a previous history of a severe drug hypersensitivity 9) Patients receiving anti-cancer drugs 10) Inappropriate patients for entry on this study in the judgement of the investigator

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Time to progression, overall survival, toxicity	—

Countries

Japan

Outcome results

None listed

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