RFA Plus Carrizumab vs Carrizumab Alone for HCC

  • End date
    Dec 30, 2026
  • participants needed
  • sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
Updated on 16 February 2022
immunosuppressive agents
liver transplant
hepatocellular carcinoma
Accepts healthy volunteers


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.


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.

Condition Tumor Immunity, Immunosuppression, Radiofrequency Ablation
Treatment Radiofrequency ablation
Clinical Study IdentifierNCT04150744
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Last Modified on16 February 2022


Yes No Not Sure

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
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