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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
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.
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Response rates
Describe the overall response rate with a 95% confidence interval.
Time frame: 4 months
Progress free survivial
Describe median PFS with a 95% confidence interval.
Time frame: 2 years
Toxicity of HAI
Toxicity as measured by NCI Common Toxicity Criteria
Time frame: 1 months
Overall survival
Describe median overall survival with a 95% confidence interval and estimate the overall survival rate at 12 and 24 months with 24 months with a 95% confidence interval.
Time frame: 3 years
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