Clinical Trial

HAIC With One-day FOLFOX vs. HAIC With Two-day FOLFOX for Unresectable HCC: a Non-inferiority Study

Recruiting Phase 3
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Record status
This record was last updated December 9, 2022 (before its estimated July 1, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2022-07-26.
Trial Details
NCT Number NCT05476432
Lead Sponsor Sun Yat-sen University
Collaborators: Guangzhou No.12 People's Hospital, First People's Hospital of Foshan
Conditions Hepatocellular Carcinoma
Enrollment 300 participants
Start Date 2022-07-26
Primary Completion 2025-07-01 (estimated)
Study Completion 2026-10-01 (estimated)
Updated on ClinicalTrials.gov 2022-12-09