The maintenance therapy by Gemcitabine after the Gemcitabine(GEM)+Cisplatin (CDDP) combined therapy over a postoperative recurrence / advanced biliary tract cancer:a phase II, multicenter study

The maintenance therapy by Gemcitabine after the Gemcitabine(GEM)+Cisplatin (CDDP) combined therapy over a postoperative recurrence / advanced biliary tract cancer:a phase II, multicenter study - The maintenance therapy by Gemcitabine after the Gemcitabine(GEM)+Cisplatin (CDDP) combined therapy over a postoperative recurrence / advanced biliary tract cancer:a phase II, multicenter study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012983

Enrollment

Registered

2014-01-28

Start date

2012-01-04

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

biliary tract cancer

Interventions

GEM+CDDP combination therapy GEM: 1,000mg/m2, day1,8 CDDP: 25mg/m2, day1,8 repeated every 3 weeks x 6 cycles GEM: 1,000mg/m2, day1,8,15 repeated every 4 weeks until PD.

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 with the treatment except the operation is not provided(excepted biliary drainase) 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 >= 10g/dl, total bilirubin <= 2 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, creatinine clearance >= 45ml/minute 7) Patients who expect to survive more than three months. 8) Written informed consent is required from all patients.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
progression-free survival	—

Countries

Japan

Contacts

Public ContactHirofumi Kawamoto

Kawasaki Medical School General Internal Medicine 2

hirofumi.kawamoto@gmail.com086-225-2111

Outcome results

None listed

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