A Phase I study of adjuvant chemotherapy with gemcitabine plus S-1 in patients with biliary tract cancer undergoing curative resection without major hepatectomy

A Phase I study of adjuvant chemotherapy with gemcitabine plus S-1 in patients with biliary tract cancer undergoing curative resection without major hepatectomy - A Phase I study of adjuvant chemotherapy with GS in biliary tract cancer undergoing resection without major hepatectomy

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007454

Enrollment

Registered

2012-04-01

Start date

2012-04-01

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 undergoing curative resection without major hepatectomy

Interventions

Dose of gemcitabine and S-1 and treatment schedule

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Biliary tract cancer (BTC) with more than stage IB 2) BTC undergoing R0 or R1 resection without major hepatectomy 3) Older than 20 years old 4) PS0 or 1 5) No treatment other than surgery 6) No dysfunction of main organs 7) Possible oral intake 8) Treatment start; after 4 weeks and within 12 weeks after surgery 9) Obtained written informed consent

Exclusion criteria

Exclusion criteria: 1) Patients with resection of major hepatectomy 2) Patients with double cancers 3) Patients having severe allergy 4) Patients with severe organ dysfunction 5) Patients with active infectious disease 6) Pregnancy 7) Patients with severe psychological disease 8) Patients seem inadequate for this study by investigators

Design outcomes

Primary

Measure	Time frame
Maximum tolerated dose, recommended dose	—

Secondary

Measure	Time frame
Toxicity	—

Countries

Japan

Contacts

Public ContactHideyoshi Toyokawa

Kansai Medical University Department of Surgery

toyokawh@hirakata.kmu.ac.jp072-804-0101

Outcome results

None listed

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