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OncoMatch/Clinical Trials/NCT07053072

PD-1 mRNA LNP Vaccine for Advanced Primary Hepatocellular Carcinoma.

Is NCT07053072 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Low Dose PD-1 mRNA LNP Vaccine and Medium dose PD-1 mRNA LNP vaccines for liver cancer.

Phase 1/2RecruitingWest China HospitalNCT07053072Data as of May 2026

Treatment: Low Dose PD-1 mRNA LNP Vaccine · Medium dose PD-1 mRNA LNP vaccines · High dose PD-1 mRNA LNP vaccinesEvaluating the Safety and Efficacy of PD-1 mRNA LNP Vaccine Therapy in Patients with Primary Hepatocellular Carcinoma Who Have Failed Advanced Standard Therapy

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 2 prior lines

Must have received: standard therapy — second-line

has failed second-line standard therapy

Cannot have received: mRNA drug

Patients who have been inoculated with mRNA drugs

Cannot have received: lipid nanoparticle drug

Participation in clinical trials involving lipid nanoparticles, a component of the study vaccine

Cannot have received: other investigational drug

Participation in a clinical trial of another drug within 4 weeks

Lab requirements

Blood counts

hemoglobin ≥80g/L (no blood transfusion within 14 days); neutrophil count >1.5×10^9 /L; platelet count ≥80×10^9 /L

Kidney function

endogenous creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula)

Liver function

total bilirubin ≤1.5 × ULN; ALT or AST ≤ 2.5 × ULN; if liver metastases, ALT or AST ≤ 5 × ULN

Cardiac function

left ventricular ejection fraction (LVEF) ≥50%

Good function of major organs, i.e., relevant examination indexes within 14 days prior to randomization meet the following requirements: Routine blood tests: hemoglobin ≥80g/L (no blood transfusion within 14 days); neutrophil count >1.5×10^9 /L; platelet count ≥80×10^9 /L; Biochemical tests: total bilirubin ≤1.5 × ULN (upper limit of normal); blood alanine aminotransferase (ALT) or blood alanine transaminase (AST) ≤ 2.5 × ULN; if liver metastases, ALT or AST ≤ 5 × ULN; endogenous creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula); cardiac Doppler ultrasound: left ventricular ejection fraction (LVEF) ≥50%.

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

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