Hepatocellular carcinoma
Conditions
Interventions
Treatment group:Use of mRNA immunotherapy techniques
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Sign the written informed consent form (1) Subjects must sign and date an EC-approved written informed consent in accordance with the guidelines of the competent authority and the investigational institution. Informed consent must be signed prior to any protocol-related procedures that are not part of the subject's routine medical treatment. (2) Subjects must be willing and able to comply with the visits, treatment regimen, laboratory tests, and other requirements of the study as specified in the schedule. 2. Male or female patients: >= 18 years of age; = 10 mm, lymph node lesion CT scan short diameter >= 10 mm, scan layer thickness not more than 5 mm) and the lesion has not received previous local treatment (TACE, radiofrequency ablation, radiotherapy, etc.). 7. ECOG physical status score: 0 to 2 points. 8. Child-Pugh score = 3 months. 10. Good major organ function, i.e., relevant examination indexes met the following requirements within 14 days before randomization (no blood or blood products transfusion, no hematopoietic stimulating factors, no albumin or blood products). Routine blood tests: hemoglobin >= 80 g/L; neutrophil count > 1.5 × 10^9/L; platelet count >= 50 × 10^9/L. Biochemical examination: total bilirubin = 60 ml/min (Cockcroft-Gault formula). Cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= 50%. 11. Good compliance and family members agreed to cooperate with survival follow-up.
Exclusion criteria
Exclusion criteria: 1. Participation in another drug clinical trial within 4 weeks. 2. Patients with a prior history of other neoplasms, unless in situ cervical cancer, treated squamous skin cancer or epithelial bladder tumors or other malignancies that have received radical treatment (at least 5 years prior to enrollment). 3. Patients with symptomatic or rapidly progressive central nervous system metastases, extensive pulmonary metastases causing respiratory distress; patients with tumors close to or invading major blood vessels or nerves. 4. Patients with clinical signs or diseases of the heart that have not been well controlled, such as: NYHA class 2 or higher heart failure, unstable angina pectoris, myocardial infarction within 1 year, clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention. 5. For female subjects: women during pregnancy or lactation. 6. Patients with active tuberculosis, bacterial or fungal infection (>= grade 2of NCI-CTCAE 5.0); with HIV infection. 7. Patients with a history of psychotropic substance abuse and unable to abstain or with psychiatric disorders. 8. Subjects with any active autoimmune disease or history of autoimmune disease (e.g., the following, but not limited to: uveitis, enterocolitis, pituitary inflammation, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma that has completely resolved in childhood and does not require any intervention in adulthood may be included; subjects with asthma requiring bronchodilators for medical intervention are not included). 9. Any abnormalities or permanent body art (e.g., tattoos) at the vaccination site that, in the opinion of the investigator, would prevent observation of local response at the vaccination site. 10. Patients who have been inoculated with mRNA drugs. 11. Have participated in a clinical trial involving lipid nanoparticles (one of the components of this study vaccine). 12. Presence of contraindications to intramuscular injection. 13. Have a history of substance abuse or a known medical, psychological or social condition, such as a history of alcohol or drug abuse. 14. Known allergy, hypersensitivity reaction or intolerance to the investigational vaccine (including any excipients). Prior history of severe allergy to any drug, food, vaccination, such as anaphylaxis, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, local allergic necrotizing reaction (Arthus reaction), etc.; 15. Users of immunosuppressive drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;Progression-free survival;Overall Survival; | — |
Countries
China
Contacts
Public ContactJiyan Liu
West China Hospital, Sichuan University
Outcome results
None listed