Hepatocellular Carcinoma
Conditions
Interventions
Experimental group:Radiofrequency Ablation (RFA) combined with Camrelizumab
Sponsors
Shandong Cancer Prevention and Treatment Institute
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-80 years; 2. Patients with primary hepatocellular carcinoma who strictly comply with the clinical diagnostic criteria of the code for the diagnosis and treatment of primary liver cancer (2019 Edition) or confirmed by histopathology or cytology; single tumor, diameter = 90 g/L ANC >= 1.5 x 10^9/L PLT >= 60 x 10^9/L (2) Biochemical examination: ALB >= 2^9 g/L ALT and AST < 2.5 ULN; TBIL <= 2 ULN Creatinine <= 1.5 ULN; (only one of the two indicators of albumin and bilirubin in child Pugh rating is 2 points) 9. Women of childbearing age should exclude the possibility of pregnancy before entering the group; 10. The subjects voluntarily participated in this study, without mental illness or other mental symptoms, with full civil capacity, signed informed consent, good compliance, and can cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with single tumor and diameter > 5cm; or patients with multiple tumors and maximum diameter > 3cm; 2. Patients with CNLC stage IIB liver cancer who are not suitable for radiofrequency ablation; 3. Patients with vascular, bile duct and adjacent organ invasion and distant metastasis; 4. Patients who received any local treatment (including but not limited to surgery, radiotherapy, cryoablation or percutaneous ethanol injection) within 4 weeks before participating in the study; 5. The subject has any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; the subject has vitiligo or asthma in childhood has been completely relieved, and does not need any treatment in adults) Intervention can be included; subjects need bronchodilator for medical intervention of asthma can not be included); 6. The subject is using immunosuppressant, systemic or absorbable local hormone to achieve the purpose of immunosuppression (dose > 10mg / day prednisone or other therapeutic hormones), and continues to use it within 2 weeks before entering the group; 7. Patients with severe allergic reaction to the test drug; 8. Patients with cardiac clinical symptoms or diseases that are not well controlled, for example: (1) Heart failure above NYHA grade 2 (2) Unstable angina pectoris (3) Myocardial infarction occurred within 1 year (4) Supraventricular or ventricular arrhythmias with clinical significance need treatment or intervention (5) QTc > 450 ms (male), QTc > 470 MS (female); 9. Patients with abnormal coagulation function (INR > 1.5 or PT > 16S) have bleeding tendency or are receiving thrombolytic or anticoagulant therapy; 10. Patients who had previously received radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy, subjects who were less than 4 weeks from the last medication or treatment (or 5 drug half lives, whichever is longer); patients whose adverse events (except alopecia) caused by previous treatment did not recover to 38.5 degree during screening or before the first administration; 15. Patients with previous or current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe impairment of 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 value; hepatitis C reference:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival rate (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Time To Progress (TTP);Objective response rate (ORR);Disease Control Rate (DCR); | — |
Countries
China
Contacts
Public ContactJianjun Han
Shandong Cancer Prevention and Treatment Institute
Outcome results
None listed