Overview
The study aims to find whether patients with advanced HCC can get more benefits from RFA +PD-1 immunosuppressant (carrizumab) compared with carrizumab alone, considering with the result of PFS.
Description
The study aims to find whether patients with advanced HCC can get more benefits from RFA +PD-1 immunosuppressant (carrizumab) compared with carrizumab alone, considering with the result of PFS. 120 patients were enrolled into two groups respectively, the experimental group and reference group.
Eligibility
Inclusion Criteria:
- Age from 18-75 years
- Diagnosis as hepatocellular carcinoma from histology and cytology
- BCLC B-C degree
- Score of ECOG PS: 0-2
- Child-Pugh Score: A or B
- Not suitable for resection or liver transplantation
- Have not received systemic therapy
- Have at least one evaluable target mass from CT or MRI according to mRECIST
- The estimated survival time ≥ 12 weeks
- Patients with HBV infection having HBV-DNA <500IU/mL and standard anti-virus treatment. Patients with HCV infection must receive standard anti-virus treatment.
- The function of main organs normal
- Sign informed consent
Exclusion Criteria:
- Have cholangiocarcinoma, mixed type of hepatocarcinoma and fibrolamellar hepatocellular carcinoma. Have incurable malignant tumor in five years.
- Have local ablation, TACE or radiotherapy in 3 months before enrolled.
- Prepared to or have received organic or bone marrow transplantation.
- Uncontrollable ascites, hepatic encephalopathy or esophageal and gastric varices.
- Have hypertension and can't lower down to the normal level using blood pressure medication.
- Have type II myocardial ischemia or myocardial infarction, uncontrollable arrhythmia.
- Have diseases to influent the effect of oral drugs, for example, unable to swallow, chronic diarrhea and intestinal obstruction.
- Have gastrointestinal bleeding in 6 months
- Have abdominal fistula, gastrointestinal perforation or abdominal abscess
- Patients with lung fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug related pneumonia or severe dysfunction of lung.
- Routine urine test showed urinary protein ≥++ or the 24 hours amount of urinary protein ≥1.0 g
- Patients have autoimmune disease
- Patients need corticosteroid or other immunosuppressant therapy
- Patients have anti-tumor vaccine and other immunostimulate anti-tumor drugs in 3 months
- Allergy to monocloning antibody
- Pregnant or breastfeeding female Other patients not suitable to be enrolled in the study.