a clinical study of mrna vaccine (abor2014/ipm511) in patients with advanced hepatocellular carcinoma

Conditions: Advanced Hepatocellular Carcinoma

Summary: this is an open label, single-site, investigator-initiated trial designed to evaluate the safety, tolerability and preliminary efficacy of abor2014(ipm511) injection in relapsed/ refactory hcc.


Eligibility criteria:
inclusion criteria: 1. subjects who understand and voluntarily sign the informed consent form; 2. male or female subjects ≥ 18 years old; 3. patients with pathological or cytological evidence of locally advanced or hepatocellular carcinoma, who have failed or are intolerant of previous standard treatments; 4. at least one measurable lesion judged according to the recist version 1.1 standard. 5. eastern cooperative oncology group (ecog) performance status score of 0-1 (inclusive); 6. life expectancy ≥ 12 weeks; 7. hla typing: a-02; 8. 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; 9. 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: 1. known allergy to any of the components of the investigational product; 2. history of topical treatment with mrna products or treatment with mrna vaccines; 3. 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); 4. history of anti-tumor therapies within 4 weeks before the first dose; 5. 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; 6. history of organ transplant, bone marrow transplant, or hematopoietic stem cell transplant; 7. history of hemorrhagic diseases such as anaphylactoid purpura, haemophilia and aplastic anemia; 8. history of live attenuated vaccines within 30 days before the first dose; 9. central nervous system (cns) metastases that are symptomatic, untreated, or require continuous treatment; 10. toxicological events (except alopecia and pigmentation) have not recovered to baseline or nci-ctcae v5.0 grade 0-1 after prior anti-tumor therapies; 11. history of autoimmune disorders; 12. history of immediate hypersensitivity, eczema that cannot be controlled by topical corticosteroids, or asthma; 13. uncontrollable concomitant diseases; 14. active infections currently requiring systemic anti-infective therapy; active pulmonary tuberculosis; 15. known history of human immunodeficiency virus (hiv) positive or treponema pallidum positive; 16. patients with other conditions that are not suitable for participation in the study at the discretion of the investigator.

Keywords: mrna vaccine