Two institutional trial to evaluate the feasibility and efficacy of combined adjuvant therapy with gemcitabine and cisplatin for biliary tract cancer

Two institutional trial to evaluate the feasibility and efficacy of combined adjuvant therapy with gemcitabine and cisplatin for biliary tract cancer - Evaluation of the feasibility and efficacy of combined adjuvant therapy with gemcitabine and cisplatin for biliary tract cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001294

Enrollment

Registered

2008-08-08

Start date

2008-01-01

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

Biriary tract cancer

Interventions

Administration of gemcitabine and cisplatin for adjuvant chemotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologically proven biliary tract cancer after surgical resection Stage IB,IIA, IIB,III (UICC) R0 and R1 No previous chemo- or radiotherapy within 3 years Within 8 weeks after operation PS 0 and 1 Hb >=10g/dl WBC >=3000/mm3 Neutrophil >=1500/mm3 Platelet >=100,000/mm3 AST, ALT <=150U/L T-Bil <=3mg/dl CCr >=45ml/min

Exclusion criteria

Exclusion criteria: Apparent infection Fever Heart disease Interstitial pneumonia, pulmonary fibrosis Other active cancers Brain metastasis Pericardial effusion Allergy of the drugs Pregnancy or patient's hope to be pregnant

Design outcomes

Primary

Measure	Time frame
Feasibility	—

Secondary

Measure	Time frame
Efficacy	—

Countries

Japan

Contacts

Public ContactOsamu Kainuma

Chiba Cancer Center Gastroenterological Surgery

okainuma@chiba-cc.jp043-264-5431

Outcome results

None listed

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