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RFA Plus Carrizumab vs Carrizumab Alone for HCC

RFA Plus Carrizumab vs Carrizumab Alone for HCC

Recruiting
18-75 years
All
Phase 2

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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:

  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.

Study details
    Tumor Immunity
    Immunosuppression
    Radiofrequency Ablation

NCT04150744

Second Affiliated Hospital, School of Medicine, Zhejiang University

26 January 2024

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