RecruitingPhase 2NCT04150744

RFA Plus Carrizumab vs Carrizumab Alone for HCC

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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

120 participants

Start Date

Aug 1, 2020

Study Type

INTERVENTIONAL

Conditions

Radiofrequency Ablation Tumor Immunity Immunosuppression

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria12

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 Criteria16

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.