drugset / Trial / NCT02987699
Phase II Study of HAIC Using Cisplatin,Leucovorin and 5-Fluorouracil
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this phase II study is to determine the recommended dose, as well as the safety and efficacy of the combination of oxaliplatin, leucovorin and 5-Fu introduced by hepatic arterial infusion chemotherapy (HAIC) in patients with advanced hepatocellular carcinoma (HCC).
Timeline
- Start
- 2016-11
- Primary completion
- 2017-04
- Completion
- 2017-05
Publications
- Results Llovet JM, Real MI, Montana X, Planas R, Coll S, Aponte J, Ayuso C, Sala M, Muchart J, Sola R, Rodes J, Bruix J; Barcelona Liver Cancer Group. Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. Lancet. 2002 May 18;359(9319):1734-9. doi: 10.1016/S0140-6736(02)08649-X.
- Results Llovet JM, Bruix J. Systematic review of randomized trials for unresectable hepatocellular carcinoma: Chemoembolization improves survival. Hepatology. 2003 Feb;37(2):429-42. doi: 10.1053/jhep.2003.50047.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Other |
| Subject | Oxaliplatin | Small molecule | 135 mg/m2 | Other |
| Subject | fluorouracil | Small molecule | 1400 mg/m2 | Other |
| Subject | fluorouracil | Small molecule | 2800 mg/m2 | Other |
| Background | Leucovorin | Small molecule | 400 mg/m2 | Other |