drugset / Trial / NCT03164382
Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil/Leucovorin Versus Sorafenib in Advanced Hepatocellular Carcinoma
RandomizedParallel-groupSingle-blindTreatment
Summary
This trial was designed to investigate whether the survival outcome, response rate and safety of hepatic arterial infusion of oxaliplatin, fluorouracil/leucovorin regimens for patients with Barcelona-Clinic Liver Cancer (BCLC)-C stage hepatocellular carcinoma was superior than those of the standard treatment with sorafenib or not.
Timeline
- Start
- 2017-03-01
- Primary completion
- 2020-10-31
- Completion
- 2020-11-30
Publications
- Chen QF, Jiang X, Hu Y, Chen S, Lyu N, Zhao M. Interventional arterial chemotherapy versus sorafenib for advanced hepatocellular carcinoma in China: a health economic evaluation of open-label, randomised, phase 3 study. BMJ Open. 2025 May 27;15(5):e095508. doi: 10.1136/bmjopen-2024-095508.
- Lyu N, Wang X, Li JB, Lai JF, Chen QF, Li SL, Deng HJ, He M, Mu LW, Zhao M. Arterial Chemotherapy of Oxaliplatin Plus Fluorouracil Versus Sorafenib in Advanced Hepatocellular Carcinoma: A Biomolecular Exploratory, Randomized, Phase III Trial (FOHAIC-1). J Clin Oncol. 2022 Feb 10;40(5):468-480. doi: 10.1200/JCO.21.01963. Epub 2021 Dec 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Leucovorin | Small molecule | 200 mg/m2 | Other |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | Other |
| Comparator | Sorafenib | Small molecule | 400 mg | Oral |
| Subject | fluorouracil | Small molecule | 400 mg/m2 | Other |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | Other |