OncoMatch/Clinical Trials/NCT06041477
Concurrently vs Sequentially Combined HAIC With Targeted and Immunotherapy in Potentially Resectable HCC
Is NCT06041477 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for hepatocellular carcinoma.
Treatment: Oxaliplatin,calcium folinic acid, levofolinic acid, 5-FU · Concurrent Lenvatinib · Concurrent PD-1 antibody · Sequential Lenvatinib · Sequential PD-1 antibody — The goal of this clinical trial is to compare HAIC concurrently with sequentially combined with targeted and immunotherapies in terms of efficacy and safety in patients with potentially resectable intermediate and advanced HCC (CNLC stage IIa\~IIIa). The main questions it aims to answer are: * Does a "strong combination" regimen of three simultaneous treatments (HAIC, targeted agents and immunotherapy) definitely result in a higher surgical conversion rate and better survival benefit? * Can the combination of targeted and immunotherapies based on patients' response to HAIC therapy avoid over-treatment of some patients without affecting the surgical conversion rate and overall survival? Participants will be randomly assigned to receive either HAIC concurrently or sequentially combined with targeted and immunotherapies. Researchers will compare concurrent treatment group with sequential treatment group to see if there are different in terms of the conversion resection rate, long-term survival, and safety.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Disease stage
Required: Stage IIA, IIB, IIIA (CNLC)
meeting the stage IIa-IIIa of CNLC staging
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: any treatment targeting hepatocellular carcinoma (interferon)
Not having received previous treatment against hepatocellular carcinoma; Those who have received previous treatment targeting hepatocellular carcinoma (including interferon)
Lab requirements
Blood counts
Neutrophil count ≥2.0×10^9/L; Hemoglobin ≥ 100 g/L; Platelet count ≥ 75 × 10^9/L
Kidney function
Plasma creatinine < 1.5x ULN
Liver function
Plasma albumin level ≥ 35 g/L; Plasma total bilirubin < 2x ULN; ALT < 3x ULN; AST < 3x ULN; Prothrombin time normal or ≤ 4 sec above ULN; INR ≤ 2.2
Laboratory tests meet the following conditions, or the following conditions can be achieved with short-term treatment: Neutrophil count ≥2.0×10^9/L; Hemoglobin ≥ 100 g/L; Platelet count ≥ 75 × 10^9/L; Plasma albumin level ≥ 35 g/L; Plasma total bilirubin less than 2 times the upper limit of normal; Plasma alanine aminotransferase (ALT) less than 3 times the upper limit of normal; Plasma aspartate aminotransferase (AST) less than 3 times the upper limit of normal; Plasma creatinine less than 1.5 times the upper limit of normal; Plasma prothrombin time is normal or exceeds the upper limit of normal value by ≤ 4 seconds; Prothrombinogen international normalized ratio (INR) ≤ 2.2
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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