Study of Hepatic Arterial Infusion to Treat Biliary Tract Carcinomas
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|ClinicalTrials.gov Identifier: NCT01572324|
Recruitment Status : Completed
First Posted : April 6, 2012
Last Update Posted : January 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Biliary Tract Cancer||Drug: Oxaliplatin, Fluorouracil, Leucovorin, Capecitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Hepatic Arterial Infusion With Oxaliplatin and Fluorouracil in Patients With Unresectable Biliary Tract Carcinomas|
|Study Start Date :||March 2012|
|Primary Completion Date :||October 2015|
|Study Completion Date :||April 2016|
|Experimental: Arterial infusion||
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.
- Response rates [ Time Frame: 4 months ]Describe the overall response rate with a 95% confidence interval.
- Progress free survivial [ Time Frame: 2 years ]Describe median PFS with a 95% confidence interval.
- Toxicity of HAI [ Time Frame: 1 months ]Toxicity as measured by NCI Common Toxicity Criteria
- Overall survival [ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572324
|Peking University Cancer Hospital|
|Beijing, Beijing, China, 100142|
|Principal Investigator:||Xiaodong Wang, MD||Peking University Cancer hospital & Institute|