A phase II trial of neoadjuvant chemotherapy using the combination of gemcitabine and cisplatin for patients with initially unresectable locally advanced biliary tract cancer.

A phase II trial of neoadjuvant chemotherapy using the combination of gemcitabine and cisplatin for patients with initially unresectable locally advanced biliary tract cancer. - A phase II trial of neoadjuvant chemotherapy using the combination of gemcitabine and cisplatin for patients with initially unresectable locally advanced biliary tract cancer.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015330

Enrollment

Registered

2014-10-03

Start date

2012-07-01

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

Neoadjuvant chemotherapy: 3 course of gemcitabine and cisplatin combination therapy (21days for one course: day 1 and 8 gemcitabine 1000mg/m2, cisplatin 25mg/m2) Adjuvant chemotherapy: 6 course of ge

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Initially unresectable locally advanced biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder carcinoma) proved by histological or cytological or graphical examination. 2. No distant metastasis. 3. Local invasion of the hepatic artery to be unable to reconstruct. Local invasion of the portal vein to be unable to reconstruct. Local invasion of the hepatic vein to be unable to reconstruct. Extensive infiltration of the bile duct to be unable to achieved a curative resection. Extensive hepatic invasion to be unable to excise due to insufficient remnant liver volume even after portal vein embolization 4. Age 20 or more 5. No history of primary chemotherapy and/or radiation therapy. 6. EOCG performance status 0-1 7. Sufficient organ function defined as: WBC > 3,000/mm3 ANC > 1,500/mm3 Hb > 9.0g/dl PLT > 100,000/mm3 T-Bil < upper limit X 5 AST/ALT < upper limit X 5 Creatinine < upper limit X 1.5 8. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Pulmonary fibrosis or interstitial pneumonia 2. Severe myelosuppression 3. Pregnant female, possibly pregnant females, females wishing to become pregnant, and females feeding babies. 4. Serious renal dysfunction 5. Serious liver dysfunction 6. Patients with severe allergy 7. History of breast or lung radiation 8. Active infection 9. Patient with uncontrollable pleural effusion and/or severe edema 10. Active double cancer 11. Severe complications including uncontrollable diabetes mellitus. 12. Severe mental disorder 13. Inadequate physical condition, as diagnosed by primary physician

Design outcomes

Primary

Measure	Time frame
Resection rate	—

Secondary

Measure	Time frame
1. Overall survival 2. Disease free survival 3. Progression free survival 4. Tumor response rate 5. Adverse events	—

Countries

Japan

Contacts

Public ContactAtsushi Kato

Chiba University Graduate School of Medicine Depertment of General Surgery

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

Outcome results

None listed

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