Hepatocellular carcinoma
Conditions
Interventions
Group A:Toriplimab is administrated 3 mg/kg intravenously every 3 weeks continuously until documented disease progression, discontinuation due to toxicity withdrawal of consent or the study ends.
Group B:One to three lesions were completely ablated under the guidance of CT or ultrasound, and toriplimab therapy was started on the third day after ablation (the dose was 3mg / kg, once every three
Sponsors
Xiangya Hospital, Central South University
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with hepatocellular carcinoma who have not undergone radical resection or radical ablation, and who have received systemic treatment and failed first-line systemic treatment, meet the clinical diagnostic criteria of my country's "Primary Liver Cancer Diagnosis and Treatment Standards (2017 Edition)" or confirmed by histopathology Hepatocellular carcinoma. 2. Age 18-75 years old, no gender limit; 3. At least one lesion that can be completely ablated by radiofrequency/microwave; 4. BCLC stage B or C; 5. Child-Pugh liver function grade A or B grade 7 points; 6. ECOG PS 0-1 points; 7. The number of intrahepatic lesions is less than 10, the single largest diameter is less than 10cm, and the tumor occupies less than 50% of the liver volume; 8. No invasion of the main portal vein; 9. The estimated survival time is greater than 3 months; 10. Understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with complicated autoimmune diseases such as hyperthyroidism, hypothyroidism; systemic lupus erythematosus, etc.; 2. Patients e who have suffered or are currently complicated with other malignant tumors (except for cured basal or squamous cell skin cancer or cervical carcinoma in situ); 3. White blood cell count 2mg/L); 5. Poor coagulation function, INR > 1.5, or undergoing anticoagulation therapy or known bleeding disorders; 6. A history of major diseases involving the heart, kidneys, bone marrow, lungs, and central nervous system; 7. Patients who need antibiotic treatment for recent infections; 8. Patients who need to use corticosteroids ( > 10 mg/day prednisone or equivalent) or other immunosuppressive agents for systemic treatment within 14 days before the first medication. 9. Patients who have been treated with anti-tumor vaccines or other anti-tumor drugs with immunostimulatory effects within 1 month before the first administration. 10. Patients with grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmia, and grade III to IV cardiac insufficiency. 11. Patients with active tuberculosis (TB). 12. Patients who have had a serious infection within 4 weeks before the first administration. Exclude subjects with any active infections. 13. Patients who are going to undergo or have previously received tissue/organ transplantation. 14. Patients who have been vaccinated or will be vaccinated with live vaccine within 30 days before the first dose. 15. Patients who have received radiofrequency, microwave, cryo, and electroporation ablation within two months. 16. Comorbidities or social environment that can prevent subjects from following the research plan or even endanger patient safety. 17. Patients who have received Chinese herbal medicines or proprietary Chinese medicines for cancer control within 14 days before the first administration of the study drug (Appendix 13). 18. Patients who have received live vaccine injections <= 4 weeks before randomization. Remarks: Seasonal flu vaccines are usually inactivated vaccines and are allowed to be used. The vaccine used in the nasal cavity is a live vaccine and is not allowed. 19. There is a basic medical condition (including abnormal laboratory test values) or alcohol/drug abuse or dependence that is not conducive to the administration of the study drug or affects the interpretation of drug toxicity or AE, or may reduce the patients compliance during the study period. 20. At the same time participate in another therapeutic clinical trial. 21. Pregnant or lactating women. 22. Have received any chemotherapy, immunotherapy (such as interleukin, interferon, thymosin) or any side effects of study treatment 14 days or 5 half-lives (whichever is longer) before the first administration of the study drug ( Patients who have not returned to baseline or stable levels due to previous anti-cancer treatments, unless it is an AE that is considered unlikely to pose a safety risk (such as hair loss and abnormal laboratory test values). 23. Have received treatment targeting PD-1, PD-L1 or PD-L2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival;Disease Control Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Overall response rate;Physic condition;Tumour marker response; | — |
Countries
China
Contacts
Public ContactShi Liangrong
Xiangya Hospital, Central South University
Outcome results
None listed