A Clinical Study of mRNA Vaccine (ABOR2014/IPM511) in Patients With Advanced Hepatocellular Carcinoma

Inclusion Criteria: Subjects who understand and voluntarily sign the informed consent form; Male or female subjects ≥ 18 years old; Patients with pathological or cytological evidence of locally advanced or hepatocellular carcinoma, who have failed or are intolerant of previous standard treatments; At least one measurable lesion judged according to the RECIST version 1.1 standard. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 (inclusive); Life expectancy ≥ 12 weeks; HLA typing: A-02; Laboratory tests at screening shall meet the following requirements: Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelet count (PLT) ≥ 90 × 10^9/L; Hemoglobin (Hb) ≥ 90 g/L; Total bilirubin (TBIL) ≤ 3 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × ULN; Blood creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (calculated based on Cockcroft-Gault formula) ≥ 45 mL/min; International normalized ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN; QTc interval (calculated based on Fridericia's formula) ≤ 450 ms for males and ≤ 470 ms for females; For subjects with hepatitis B-related primary hepatocellular carcinoma (HBV-HCC) or hepatitis C-related primary hepatocellular carcinoma (HCV-HCC), those who are with the following conditions are eligible to be enrolled: HBV-HCC: resolved HBV infection with concomitant antiviral therapy; HCV-HCC: resolved or active HCV infection , where concomitant antiviral therapy may be given for active HCV infection; 9. For patients of childbearing potential (male or female), effective contraceptive measures shall be taken during the study treatment and within 3 months after the last dose. For women of childbearing potential, a negative serum/urine HCG test result within 7 days prior to study enrollment shall be provided. Exclusion Criteria: Known allergy to any of the components of the investigational product; History of topical treatment with mRNA products or treatment with mRNA vaccines; Patients with a history of major operations within 4 weeks before the first dose, have a plan of major operations during the study (at the investigator's discretion); History of anti-tumor therapies within 4 weeks before the first dose; History of receiving immunosuppressive drugs within 4 weeks before the first dose, except for corticosteroid nasal sprays, inhalants, and systemic prednisone at a dose of ≤ 10 mg/day or similar drugs at equivalent doses; History of organ transplant, bone marrow transplant, or hematopoietic stem cell transplant; History of hemorrhagic diseases such as anaphylactoid purpura, Haemophilia and aplastic anemia; History of live attenuated vaccines within 30 days before the first dose; Central nervous system (CNS) metastases that are symptomatic, untreated, or require continuous treatment; Toxicological events (except alopecia and pigmentation) have not recovered to baseline or NCI-CTCAE v5.0 grade 0-1 after prior anti-tumor therapies; History of autoimmune disorders; History of immediate hypersensitivity, eczema that cannot be controlled by topical corticosteroids, or asthma; Uncontrollable concomitant diseases; Active infections currently requiring systemic anti-infective therapy; active pulmonary tuberculosis; Known history of human immunodeficiency virus (HIV) positive or treponema pallidum positive; Patients with other conditions that are not suitable for participation in the study at the discretion of the investigator.