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OncoMatch/Clinical Trials/NCT05476432

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

Is NCT05476432 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including FOLFOX 2d and FOLFOX 1d for hepatocellular carcinoma.

Phase 3RecruitingSun Yat-sen UniversityNCT05476432Data as of May 2026

Treatment: FOLFOX 2d · FOLFOX 1dHepatic 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.

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Disease stage

Required: Stage BCLC A, BCLC B, BCLC C (Barcelona Clinic Liver Cancer)

simultaneously staged as BCLC A, BCLC B or BCLC C based on Barcelona Clinic Liver Cancer staging system. Diagnosed as unresectable with consensus by the panel of liver surgery experts

Lab requirements

Blood counts

platelet count ≥ 75,000/μl; hemoglobin ≥ 8.5 g/dl; absolute neutrophil count (anc) >1,500/mm3; inr > 2.3 or pt/aptt within normal limits

Kidney function

serum creatinine ≤ 1.5 x upper limit of normal

Liver function

total bilirubin ≤ 30mmol/l; serum albumin ≥ 32 g/l; asl and ast ≤ 6 x upper limit of normal; no cirrhosis or cirrhotic status of child-pugh class a only

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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