Primary Hepatocellular Carcinoma
Conditions
Interventions
YMN-A02 100 µg Group:Enrolled subjects will receive a 100 µg intravenous infusion according to their assigned dose group. The dosing regimen includes 5 doses of primary immunization followed by subseq
YMN-A02 250 µg Group:Enrolled subjects will receive a 250 µg intravenous infusion according to their assigned dose group. The dosing regimen includes 5 doses of primary immunization followed by subseq
YMN-A02 500 µg Group:Enrolled subjects will receive a 500 µg intravenous infusion according to their assigned dose group. The dosing regimen includes 5 doses of primary immunization followed by subseq
YMN-A02 1000 µg Group:Enrolled subjects will receive a 1000 µg intravenous infusion according to their assigned dose group. The dosing regimen includes 5 doses of primary immunization followed by subs
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent: Signed informed consent form approved by the ethics committee; 2. Age and performance status: Aged 18–70 years; Eastern Cooperative Oncology Group (ECOG) performance status score of 0–1; 3. Patients with histologically confirmed advanced primary hepatocellular carcinoma that has progressed after treatment with anti-angiogenic targeted therapy and immune checkpoint inhibitors; 4. At least one target lesion with a measurable diameter according to RECIST criteria (longest diameter of tumor lesion >=10 mm on CT scan; short diameter of lymph node lesion >=10 mm on CT scan; slice thickness =3 months; 6. Adequate major organ function, as verified by the following laboratory and test results obtained within 14 days prior to randomization: (1) Hematology: Hemoglobin >=80 g/L (no blood transfusion within 14 days); absolute neutrophil count >1.5x10^9/L; platelet count >=80x10^9/L; (2) Biochemistry: Total bilirubin =60 mL/min (Cockcroft-Gault formula); (3) Cardiac assessment: Left ventricular ejection fraction (LVEF) >=50% as assessed by Doppler. echocardiography 7. Good compliance and follow-up agreement: The patient is compliant and the family agrees to cooperate with survival follow-up
Exclusion criteria
Exclusion criteria: 1. Participation in another clinical trial of an investigational drug within 4 weeks prior to enrollment; 2. Previous or concurrent diagnosis of another malignancy, except for the following: carcinoma in situ of the cervix, cutaneous squamous cell carcinoma, urothelial carcinoma of the bladder that has been treated with curative intent, or any other malignancy that has been treated with curative intent with no evidence of recurrence for 5 years or more; 3. Presence of poorly controlled cardiac disease or clinical symptoms, including but not limited to: New York Heart Association (NYHA) Class >=2 heart failure, unstable angina, myocardial infarction within the past year, or clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; 4. Pregnant or breastfeeding women; 5. Presence of active infection, including but not limited to: active tuberculosis, bacterial or fungal infection requiring systemic treatment (NCI-CTCAE v5.0 Grade >=2), human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) infection (HBV DNA above the upper limit of normal), or active hepatitis C virus (HCV) infection (HCV RNA above the upper limit of normal); 6. History of psychotropic substance abuse that cannot be abstained from, or history of mental disorders; 7. Presence of active autoimmune disease or history of autoimmune disease (including but not limited to: uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism, etc.). The following are exceptions: vitiligo controlled with topical medication only; childhood asthma that has completely resolved and requires no intervention in adulthood; patients with asthma requiring bronchodilators for medical intervention are not eligible; 8. Prior vaccination with any mRNA-based drug or mRNA formulation; 9. Prior participation in clinical trials involving lipid nanoparticle (LNP) formulations; 10. Contraindications to intravenous infusion; 11. History of drug abuse, or medical, psychological, or social conditions (such as history of alcoholism or drug addiction) that, in the investigator's judgment, may affect compliance with the study; 12. Known allergy, hypersensitivity, or intolerance to any component of the study formulation (including active ingredients and excipients); history of severe drug, food, or vaccine allergy, including but not limited to: anaphylactic shock, allergic laryngeal edema, allergic dyspnea, anaphylactoid purpura, thrombocytopenic purpura, or Arthus reaction; 13. Pregnancy plan (for female subjects or partners of male subjects) from the screening period until 12 months after the last dose; 14. Any concomitant disease that, in the investigator's judgment, may jeopardize patient safety or interfere with the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of Dose-Limiting Toxicity (DLT); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS);Objective Response Rate (ORR);Disease control rate;Duration of relief;Overall Survival;Lymphocyte Subsets;Maturation and Activation Status of Dendritic Cells (DCs);Activated T Cells;Tumor-Infiltrating T Lymphocytes (TILs);Levels of TGF-ß in Serum and Tumor Tissues;Delayed-Type Hypersensitivity (DTH); | — |
Countries
China
Contacts
Public ContactXingchen Peng
West China Hospital, Sichuan University
Outcome results
None listed