A multicenter phase II trial of pre-operative chemotherapy with Gemcitabine/ Cisplatin /S-1 for biliary tract cancers with lymph node metastasis diagnosed by FDG-PET

A multicenter phase II trial of pre-operative chemotherapy with Gemcitabine/ Cisplatin /S-1 for biliary tract cancers with lymph node metastasis diagnosed by FDG-PET - A multicenter phase II trial of pre-operative chemotherapy with GCS for biliary tract cancers with lymph node metastasis diagnosed by FDG-PET

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009831

Enrollment

Registered

2013-02-01

Start date

2013-03-01

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 cancers

Interventions

Pre-operative chemotherapy (GCS) 3 cycles-FDG-PET-surgery GCS therapy Gemcitabine 1000mg/m2/day1 Cisplatin 25mg/m2/day1 S-1 100mg/body/day1-7

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with radiologically proven bilialy tract cancer. 2.No extrahepatic disease. 3.No prior therapy. 4.The function of the liver is kept as satisfied after hepatectomy. 5.No chronic liver damage. 6.Patients of age over 20 years. 7.ECOG performance status of 0-1. 8.Sufficient organ function. 9.Patients obtained written informed consent.

Exclusion criteria

Exclusion criteria: 1. Massive abdominal effusion requiring treatment. 2. Active concomitant malignancy. 3. The case suspected of infection. 4. Patients with water solubility diarrhea. 5. Mental disease or psychotic manifestation. 6. Under continuous steroid therapy. 7. Patients with acute myocardial infaction. 8. Patients with severe complications. 9. Pregnancy or the desire to preserve fecundity. 10. Serious drug hypersensitivity or a history of drug allergy. 11. Any patients judged by the investigator to be unfit to participate in the study.

Design outcomes

Primary

Measure	Time frame
Curative resection rate	—

Countries

Japan

Contacts

Public ContactSatoru Seo

Kyoto University Graduate School of Medicine Department of Hepato-Biliary-Pancreatic Surgery and Transplantation

rutosa@kuhp.kyoto-u.ac.jpKH075-751-3242

Outcome results

None listed

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