RFA Plus Carrizumab vs Carrizumab Alone for HCC

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Radiofrequency Ablation Plus Carrizumab vs Carrizumab Alone for Moderate or Advanced Hepatocellular Carcinoma: A Real World Study

Conditions
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Tumor Immunity, Immunosuppression, Radiofrequency Ablation

Intervention / Treatment
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* Combination Product: radiofrequency ablation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RFA plus carrizumab<br> | Combination Product: radiofrequency ablation<br>* take advantage of RFA to destroy hepatocellular carcinoma by high temperature<br>|
| Placebo Comparator: carrizumab<br> | Combination Product: radiofrequency ablation<br>* take advantage of RFA to destroy hepatocellular carcinoma by high temperature<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Time from patients received treatment fist time to disease progress or death | through study completion, an average of 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | The ratio of patients with regressive disease ,including complete response and partial response | through study completion, an average of 4 years | 
| Disease control rate | The ratio of patients with regressive or stable disease, including complete response, partial response and stable disease. | through study completion, an average of 4 years | 
| Overall survival | Time from the random assignment to death (the last follow-up time for patients lost to follow-up, the end of study for patients still alive | through study completion, an average of 4 years | 
| Duration of response | Time from the first time of complete regression or partial regression to progressive disease or death | through study completion, an average of 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RFA, immunosuppressant, hepatocellular carcinoma