hepatocellular carcinoma
Conditions
Interventions
1:radical radio frequency ablation
2:combined use of tislelizumab after radical radio frequency ablation
Sponsors
Shandong Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 to 80 years; 2. Patients initially diagnosed as hepatocellular carcinoma according to the diagnostic criteria by histopathology or cytology of China Primary Liver Cancer Diagnosis and Treatment Regulations (2019 edition),with single tumor, diameter =90 g/L ;Absolute neutrophil count(ANC)>=1.5x10^9/L; Platelet(PLT)>=60x10^9/L 2 )biochemical test: ALB >=29 g/L; Alanine aminotransferase(ALT)<2.5 ULN; Aspartate transferase(AST)<2.5 ULN; Total bilirubin(TBIL)<=2 ULN; Creatinine(Cr)<=1.5 ULN(Only one of the two indicators of albumin and bilirubin in Child-Pugh classification is 2 points); 9. Female patients of childbearing age must rule out the possibility of pregnancy before enrollment; 10. Sign written informed consent and be able to comply with the visits and related procedures set out in the programme.
Exclusion criteria
Exclusion criteria: 1. single tumor, diameter>5cm; or multiple tumors, maximum diameter>3cm; 2. vascular, bile duct and adjacent organ invasion and distant metastasis; 3. Patients with Grade C of Child-Pugh; 4. Patients have received any local treatment other than radiofrequency ablation, resection (including but not limited to radiotherapy, TACE, cryoablation or ethanol injection); 5. Patients with any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or complete remission of asthma in childhood, without any intervention after adulthood can be included; subjects with asthma requiring bronchodilators for medical intervention can not be included); 6. Patients is using immunosuppressive agents, or systemic, or absorbable local hormone therapy to achieve the purpose of immunosuppression (dose > 10 mg/day prednisone or other effective hormones), and continues to use 2 times before enrollment; 7. severe allergic reactions to the test drug; 8. patients with uncontrolled cardiac clinical symptoms or diseases, such as: (1) New York Heart Association Grade II or higher heart failure; (2) unstable angina; (3) myocardial infarction within 1 year; (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; (5) QTc>450ms (male); QTc>470ms (female); 9. Patients with severe bleeding tendency or coagulopathy(INR > 1.5 or PT > 16s) or receiving thrombolytic therapy. 10. Patients who previously received radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy, less than 4 weeks from medication or treatment (or 5 drug half-lives, calculated by the longer); patients whose adverse events caused by previous treatment (except alopecia) have not recovered to 38.5 degrees during screening and before the first dose; 15. Patients with previous and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severely impaired pulmonary function; 16. Patients with congenital or acquired immune deficiency (such as HIV infection), or active hepatitis (hepatitis B reference: HBV DNA detection value exceeds the upper limit of normal; hepatitis C reference: HCV virus or RNA detection value exceeds the upper limit of normal); 17. Patients receiving treatments from other clinical trials within 4 weeks before the start of the study treatment. 18. Patients diagnosed as other malignant tumors (except cured cutaneous basal cell carcinoma and cervical carcinoma in situ); 19. Patients may receive other systemic anti-tumor therapy during the study; 20. Patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year Recurrence-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year overall survival rate;Time to Progression;Objective response rate;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactJianjun Han
Shandong Cancer Hospital
Outcome results
None listed