Liver cancer
Conditions
Interventions
Experimental group:Radiofrequency ablation combined with trepril mAb
Sponsors
The fifth medical center of PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Men or women over the age of 18 years; 2. Patients who were definitely diagnosed as HCC and relapsed within 6 months after RFA treatment or who were treated with RFA more than 3 times; 3. The recurrent lesions are suitable for radiofrequency ablation (RFA); 4. Grade A and B of liver function, no encephalopathy or ascites (small amount) at present; 5. Left ventricular ejection fraction (LVEF) >=50%; 6. ECoG physical state 0-1; 7. Baseline laboratory examination (repeated laboratory examination is allowed during screening to evaluate the qualification of subjects, and laboratory results must be within the scope of protocol before study treatment); (1) Absolute count of neutrophils > 1.5x10^9; (2) Platelet count > 75 x10^9; (3) HGB > 10.0 g / dl (unless the hemoglobin value is stable, the cardiovascular system of the subject is in a stable state, without symptoms, and it is judged to be able to withstand the RFA procedure); Note: if clinically proven, subjects can receive platelet or concentrated RBC infusion, and can be reevaluated after treatment. 8. Creatinine clearance (CrCl) >=60 mol / min at baseline. Serum bilirubin 2.8 g/dl; 9. Sign the informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Estimated ablation volume > 30% of total liver volume; 2. In the past 6 months, he has suffered from serious medical diseases, including but not limited to heart failure, myocardial infarction or cerebrovascular accident, or fatal arrhythmia; 3. Previously received any other immunotherapy other than the program; 4. Extrahepatic metastasis; 5. Tumor infiltration / thrombosis of portal vein or hepatic vein; 6. The body temperature was more than 38.3 degree C immediately before the study and treatment, and antibiotic treatment was used within 1 month before the group was enrolled; 7. The international standardized ratio was 1.5 times higher than the upper limit of normal value (Unl) of the research center. Unless anticoagulant therapy is not associated with HCC, such as AF. After the disease has been cured or the anticoagulant has been stopped, the subjects can be screened again; 8. It has the contraindications of using PD-1; 9. Being treated with other investigational drugs; 10. There are other malignant tumors (the subjects who have received treatment of skin squamous cell carcinoma or basal cell carcinoma can be included in this study). There is evidence that the primary malignant tumor is extrahepatic tumor or clinically significant active infection; 11. HIV positive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival time;The expression of PD-L1 in circulating tumor cells; | — |
Countries
China
Contacts
Public ContactHui Xie
The fifth medical center of PLA General Hospital
Outcome results
None listed