PD-1 mRNA LNP Vaccine for Advanced Primary Hepatocellular Carcinoma.
Trial Parameters
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Brief Summary
Evaluating the Safety and Efficacy of PD-1 mRNA LNP Vaccine Therapy in Patients with Primary Hepatocellular Carcinoma Who Have Failed Advanced Standard Therapy
Eligibility Criteria
Inclusion Criteria: 1. Male or female patients: ≥18 years of age; ≤70 years of age; 2. Recurrent or metastatic hepatocellular carcinoma that has failed second-line standard therapy. 3. Patients with at least one target lesion with a measurable diameter according to the RECIST criteria (CT scan of tumor lesions with a long diameter of ≥10mm, CT scan of lymph node lesions with a short diameter of ≥10mm and a layer thickness of no more than 5mm); 4. ECOG physical condition score: 0 to 1; 5. Expected survival ≥ 3 months; 6. 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 \>1.5×109 /L; platelet count ≥80×109 /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 × UL