A randomized phase II study of Gemcitabine or Gemcitabine + S-1 as adjuvant chemotherapy for resected biliary tract cancer

A randomized phase II study of Gemcitabine or Gemcitabine + S-1 as adjuvant chemotherapy for resected biliary tract cancer - A randomized phase II study of Gemcitabine or Gemcitabine + S-1 as adjuvant chemotherapy for resected biliary tract cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007244

Enrollment

130

Registered

2012-02-10

Start date

2009-01-01

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

Biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder carcinoma)

Interventions

GEM : day 1, 8, 15 1000mg/m2 IV q4 weeks 12 cycles GEM : day 8, 15 1000mg/m2 IV TS-1 : day 1-14 60mg/m2 PO q3 weeks 16 cycles

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Biliary tract cancer. Histologically or cytologically confirmed adenocarcinoma, adenosquamous carcinoma. Surgical resection (Cur B/C, Nodal status (+)) (2) No previous chemotherapy against biliary tract cancer. (3) No previous radiotherapy against biliary tract cancer. (4) EOCG performance status of 0-2 (5) Age over 20 (6) Have a life expectancy of at least 2 months (7) Sufficient organ function defined as : Hb over 9.0g/dl WBC over 3000/mm3 ANC over 1500/mm3 PLT over 100,000/mm3 AST/ALT under upper limit X 2.5 T-Bil & under upper limit X 3 Creatinine upper limit (8) Written informed consent

Exclusion criteria

Exclusion criteria: (1) active interstitial pneumonia (2) unstable pleural effusion (3) with metastasis (4) patients with uncured other malignancies (5) active severe infection (6) patients with severe complication (7) patients with uncontrollable angina pectoris or a new onset of myocardial infarction within 3 months (8) uncontrollable diabetes mellitus, hypertension (9) psychiatric disorder (10) women in pregnancy, potential pregnancy, or breast feeding (11) other inappropriate cases according to primary doctor's evaluation

Design outcomes

Primary

Measure	Time frame
Disease Free Survival	—

Secondary

Measure	Time frame
Overall Survival Safety Completion rate	—

Countries

Japan

Contacts

Public ContactAtsushi Kato

Chiba University Graduate School of Medicine Department of General Surgery

akato@faculty.chiba-u.jp043-226-2103

Outcome results

None listed

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