Immunosuppression Clinical Trial
Official title:
Radiofrequency Ablation Plus Carrizumab vs Carrizumab Alone for Moderate or Advanced Hepatocellular Carcinoma: A Real World Study
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | December 30, 2026 |
Est. primary completion date | December 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Age from 18-75 years 2. Diagnosis as hepatocellular carcinoma from histology and cytology 3. BCLC B-C degree 4. Score of ECOG PS: 0-2 5. Child-Pugh Score: A or B 6. Not suitable for resection or liver transplantation 7. Have not received systemic therapy 8. Have at least one evaluable target mass from CT or MRI according to mRECIST 9. The estimated survival time = 12 weeks 10. Patients with HBV infection having HBV-DNA <500IU/mL and standard anti-virus treatment. Patients with HCV infection must receive standard anti-virus treatment. 11. The function of main organs normal 12. Sign informed consent Exclusion Criteria: 1. Have cholangiocarcinoma, mixed type of hepatocarcinoma and fibrolamellar hepatocellular carcinoma. Have incurable malignant tumor in five years. 2. Have local ablation, TACE or radiotherapy in 3 months before enrolled. 3. Prepared to or have received organic or bone marrow transplantation. 4. Uncontrollable ascites, hepatic encephalopathy or esophageal and gastric varices. 5. Have hypertension and can't lower down to the normal level using blood pressure medication. 6. Have type II myocardial ischemia or myocardial infarction, uncontrollable arrhythmia. 7. Have diseases to influent the effect of oral drugs, for example, unable to swallow, chronic diarrhea and intestinal obstruction. 8. Have gastrointestinal bleeding in 6 months 9. Have abdominal fistula, gastrointestinal perforation or abdominal abscess 10. Patients with lung fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug related pneumonia or severe dysfunction of lung. 11. Routine urine test showed urinary protein =++ or the 24 hours amount of urinary protein =1.0 g 12. Patients have autoimmune disease 13. Patients need corticosteroid or other immunosuppressant therapy 14. Patients have anti-tumor vaccine and other immunostimulate anti-tumor drugs in 3 months 15. Allergy to monocloning antibody 16. Pregnant or breastfeeding female Other patients not suitable to be enrolled in the study. |
Country | Name | City | State |
---|---|---|---|
China | the Second Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival | Time from patients received treatment fist time to disease progress or death | through study completion, an average of 4 years | |
Secondary | Objective response rate | The ratio of patients with regressive disease ,including complete response and partial response | through study completion, an average of 4 years | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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