A Prospective，Single Arm Clinicial Trial Evaluating PD-1 mRNA LNP Vaccine for the Treatment of Advanced Primary Hepatocellular Carcinoma Failing Standard Therapy
Evaluating the Safety and Efficacy of PD-1 mRNA LNP Vaccine Therapy in Patients with Primary Hepatocellular Carcinoma Who Have Failed Advanced Standard Therapy
• Male or female patients: ≥18 years of age; ≤70 years of age;
• Recurrent or metastatic hepatocellular carcinoma that has failed second-line standard therapy.
• 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);
• ECOG physical condition score: 0 to 1;
• Expected survival ≥ 3 months;
• 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 × ULN; endogenous creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula);
⁃ cardiac Doppler ultrasound: left ventricular ejection fraction (LVEF) (LVEF) ≥50%.
• Good compliance and family agreement to cooperate in receiving survival follow-up.