Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142, China
NCT Number: NCT01572324
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Beijing, Beijing Municipality, 100142, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: 1-OHP, Dacotin, Eloxatin, L-OHP;, 5-Fluorouracil,5FU;, Levofolinic acid,Folinic acid.
Time frame: 4 months
Describe the overall response rate with a 95% confidence interval.
Time frame: 2 years
Describe median PFS with a 95% confidence interval.
Time frame: 1 months
Toxicity as measured by NCI Common Toxicity Criteria
Time frame: 3 years
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.
Peking University
Other
Phase II Study of Hepatic Arterial Infusion With Oxaliplatin and Fluorouracil in Patients With Unresectable Biliary Tract Carcinomas
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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