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

StatusUnknown
PhasePhase 3
Started

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.

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Dec 2022); last known: Recruiting
  2. Secondary endpoints: details revised at 4 of 4 entriesv2
  3. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 Hepatocellular Carcinoma
Related terms Carcinoma, Hepatocellular
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov