Phase I study of GEM or S-1 adjuvant therapy after hemihepatectomy for biliary tract cancer (KHBO1003)

Phase I study of GEM or S-1 adjuvant therapy after hemihepatectomy for biliary tract cancer (KHBO1003) - Phase I study of GEM or S-1 adjuvant therapy after hemihepatectomy for biliary tract cancer (KHBO1003)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004682

Enrollment

Registered

2010-12-10

Start date

2010-12-01

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 (Including intrahepatic cholangiocarcinoma)

Interventions

Gemcitabine 800mg/m2 - 1000mg/m2, day 1 every 3 weeks. day 1, 15 every 4 weeks. day 1, 8 every 3 weeks. day 1, 8, 15, every 4 weeks. S-1 40mg/day - 120mg/day (depend on BSA) day 1-14, ev

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Biliary tract cancer (>= UICC Stage IB) 2) R0 or R1 resection 3) ECOG PS 0 or 1 4) No other treatment than surgery for BTC 5) Neutrophil >= 1500/uL, PLT >=100,000/uL, AST, ALT <= x5 ULN, Total Bilirubin <= x3 ULN, crtn <1.2 mg/dL 6) Oral drug intake 7) 4 - 12 weeks after the surgery 8) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Active double cancer 2) Severe drug allergy 3) Severe complications (IP, HF, RF, LF, ileus, DM, etc) 4) Active infections 5) Pregnancy 6) Severe mental disorder 7) Others

Design outcomes

Primary

Measure	Time frame
MTD and RD	—

Countries

Japan

Contacts

Public ContactShogo Kobayashi

Osaka University Surgery

Outcome results

None listed

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