HCC
Conditions
Interventions
Experimental group:Multimodal thermal therapy,Tislelizumab
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily join this study and sign the informed consent form; 2. 18-75 years old, male or female; 3. Patients with first-time relapse of HCC; 4. Liver lesions with imaging evaluable points: the number of intrahepatic lesions does not exceed 3, and the maximum diameter of the lesion is = 3cm; 5. Neutrophil percentage>50%, neutrophil count (ANC) >=1.5×10^9/L, hemoglobin (HB)>=10.0g/dl, platelet (PLT)>=75×10^9/L; Biochemistry: ALT and AST=60ml/min; 6. Coagulation: APTT<=1.0×ULN, INR<=1.2×ULN. Patients on anticoagulant therapy APTT, INR<=3×ULN, need to stop anticoagulant drugs for one week before ablation therapy; 7. Child-Pugh score <=7 points; 8. ECOG-PS score is 0 ~ 1 point.
Exclusion criteria
Exclusion criteria: 1. Invasion of portal vein trunk; 2. Less than 15-30 days of discontinuation of systematic treatment; 3. Diffuse liver cancer; 4. Combined with vascular invasion within the main trunk and secondary branches of the portal vein or hepatic veins; 5. Liver function Child grade C, no improvement after active liver protection treatment; 6. Uncorrectable abnormal coagulation function: platelet 18s, prothrombin activity <40%, and cannot be corrected; 7. Previous immunosuppressive therapy such as PD-1/L1 in the neoadjuvant/adjuvant therapy stage, and relapse during the treatment period or the time of relapse < 6 months after the end of treatment; 8. Received immunotherapy and had grade 3 or above irAEs (except for thyroid dysfunction and abnormal blood glucose); 9. Impaired consciousness, intractable massive thoracic ascites or cachexia; Uncontrollable active infection; 10. Women of childbearing age who are pregnant or lactating, or who have a pregnancy plan during the study treatment period and within 3 months after the end of treatment; 11. The investigator thinks that it is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year RFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse-free survival (RFS);Overall Survival (OS);Intraoperative pain score;Postoperative complication rate;Immune indicators;Safety (Adverse Events); | — |
Countries
China
Contacts
Public ContactChihan Peng
West China Hospital of Sichuan University
Outcome results
None listed