drugset / Trial / NCT05476432
HAIC With One-day FOLFOX vs. HAIC With Two-day FOLFOX for Unresectable HCC: a Non-inferiority Study
Phase 3
Recruiting
300 enrolled
Sun Yat-sen University
First People's Hospital of Foshan · collabGuangzhou No.12 People's Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Hepatic arterial infusion chemotherapy (HAIC) with oxaliplatin\&5-fluorouracil was effective in unresectable hepatocellular carcinoma (HCC). The program of FOLFOX-HAIC in HCC was performed for 1 day (HAIC 1d) or 2 days (HAIC 2d). We hereby retrospectively compared the efficacy and safety between these two treatment regimens, and explored the predictive power of thymidylate synthase (TYMS), an enzyme involved in the DNA synthesis process and metabolism of fluorouracil. Patients with HCC staged BCLC A-B receive HAIC only, and patients with HCC staged BCLC C receive HAIC plus systemic treatment, such as sorafenib, A+T, lenvatinib.
Timeline
- Start
- 2022-07-26
- Primary completion
- 2025-07-01
- Completion
- 2026-10-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | fluorouracil | Small molecule | 2400 mg/m2 | Other |
| Comparator | Leucovorin | Small molecule | — | Other |
| Comparator | Oxaliplatin | Small molecule | — | Other |