drugset / Trial / NCT04687163
Sorafenib or Lenvatinib Plus HAIC of 130 mg/m² Oxaliplatin, and 5-fu vs Sorafenib or Lenvatinib Plus HAIC of 85mg/m² Oxaliplatin, and 5-fu for Unresectable Advanced HCC: a Randomised Phase 3 Trial
Phase 3
Unknown
400 enrolled
Sun Yat-sen University
Guangzhou No.12 People's Hospital · collabKaiping Central Hospital · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
A randomized trial showed that sorafenib plus hepatic artery infusion of 85mg/m² oxaliplatin, leucovorin and fluorouracil is more effective than sorafenib in advanced hepatocellular carcinoma. However, a retrospective study showed that hepatic artery infusion of 130 mg/m² oxaliplatin, leucovorin and fluorouracil is more effective than sorafenib in advanced hepatocellular carcinoma. It is unknown which oxaliplatin dose is better.
Timeline
- Start
- 2020-12-30
- Primary completion
- 2022-12-01
- Completion
- 2022-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Other |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | Other |
| Background | Lenvatinib | Small molecule | 8 mg | — |
| Background | Lenvatinib | Small molecule | 12 mg | — |
| Background | Leucovorin | Small molecule | — | Other |
| Background | Sorafenib | Small molecule | 400 mg | — |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Other |