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Recruiting Phase 2 NCT04150744

RFA Plus Carrizumab vs Carrizumab Alone for HCC

Trial Parameters

Condition Tumor Immunity
Sponsor Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 120
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2020-08-01
Completion 2025-12-30
Interventions
radiofrequency ablation

Brief Summary

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.

Eligibility Criteria

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 esop

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