NCT01572324

Study of Hepatic Arterial Infusion to Treat Biliary Tract Carcinomas

Phase II Study of Hepatic Arterial Infusion With Oxaliplatin and Fluorouracil in Patients With Unresectable Biliary Tract Carcinomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase II clinical trial is to study the effectiveness and safety of continuous hepatic arterial infusion (HAI) of Oxaliplatin and Fluorouracil in Patients with Unresectable Biliary tract carcinomas, and to explore a better first-line treatment regimen for these patients.

Conditions

• Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	Oxaliplatin, Fluorouracil, Leucovorin, Capecitabine	HAI of Oxaliplatin and Fluorouracil: Oxaliplatin 130mg/m2 in split daily doses for 3 days, Fluorouracil 3000 mg/m2 in split daily doses for 3 days. Intraarterial Oxaliplatin plus intravenous Leucovorin 200 mg/m2 simultaneously over 2 hours followed by intraarterial Fluorouracil over 22 hours on Days 1-3 of each cycle, repeat every 21 days. After 4-6 cycles of HAI, maintenance treatment continue, Maintenance of Oral capecitabine 1,000 mg/m2 twice a day from days 1-14, Cycles were repeated every 21 days.

Timeline

• Start date: 2012-03-01
• Primary completion: 2015-10-01
• Completion: 2016-04-01
• First posted: 2012-04-06
• Last updated: 2017-01-04

Locations

1 site across 1 country: China