HAIC Versus Systemic Chemotherapy for Unresectable ICC
- Sponsor
- Shi Ming
- Study ID
- NCT03771846
- Phase
- PHASE3
- Status
- Unknown
Conditions
- Intrahepatic Cholangiocarcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- irinotecan, oxaliplatin , fluorouracil, and leucovorin — DRUGadministration of irinotecan, oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
- gemcitabine and oxaliplatin — DRUGadministration of gemcitabine and oxaliplatin via vein
Study Details
The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) of irinotecan, oxaliplatin, 5-fluorouracil and leucovorin compared systemic chemotherapy of gemcitabine and oxaliplatin in patients with unresectable intrahepatic cholangiocarcinoma.
Key Dates
- Start date
- Aug 1, 2018
- Status verified
- Dec 2019
- Primary completion
- Aug 1, 2022
- Completion
- Aug 1, 2022
Study Design
- Enrollment
- 188 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Hepatic artery infusion chemotherapyParticipants received hepatic artery infusion chemotherapy of irinotecan, oxaliplatin, 5-fluorouracil and leucovorin
- Active Comparator: Systemic chemotherapyParticipants received systemic chemotherapy of gemcitabine and oxaliplatin
Primary Outcome Measure
Overall survival [ Time Frame: 12 months ]
Central Contacts
- Ming Shi, MD(8620)-87343938
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