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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004622

Enrollment

Registered

2011-01-01

Start date

2011-02-01

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 cisplatin 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 othe than surgery 6) No dyfunction 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) Patiens with active infectious disease 6) Pregnancy 7) Patients with severe psychological disease 8) Patients seems 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 ContactTetsuo Ajiki

Kobe University Graduate School of Medicine Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery

ajiki@med.kobe-u.ac.jp078-382-6302

Outcome results

None listed

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