drugset / Trial / NCT04667351
HAIC of Oxaliplatin, and 2400 mg/m² 5-fu vs HAIC of Oxaliplatin, and 1200 mg/m² 5-fu for Unresectable HCC: a Randomised Phase 3 Non-inferiority Trial
Phase 3
Unknown
400 enrolled
Sun Yat-sen University
Guangzhou No.12 People's Hospital · collabKaiping Central Hospital · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
Hepatic artery infusion of oxaliplatin, leucovorin and 2400 mg/m² fluorouracil is effective in hepatocellular carcinoma. However, SILIUS study showed that sorafenib plus hepatic artery infusion of cisplatin and fluorouracil did not significantly improve overall survival compared with sorafenib alone. Whether fluorouracil is effevtive is known.
Timeline
- Start
- 2019-03-01
- Primary completion
- 2022-12-01
- Completion
- 2022-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | fluorouracil | Small molecule | 1200 mg/m2 | Other |
| Comparator | fluorouracil | Small molecule | 2400 mg/m2 | Other |
| Comparator | Leucovorin | Small molecule | — | Other |
| Comparator | Oxaliplatin | Small molecule | — | Other |