RFA Plus Carrizumab vs Carrizumab Alone for HCC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
About this trial
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
This trial accepts healthy volunteersQualifiers
Age from 18-75 years
Diagnosis as hepatocellular carcinoma from histology and cytology
BCLC B-C degree
Score of ECOG PS: 0-2
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
radiofrequency ablation
Combination producttake advantage of RFA to destroy hepatocellular carcinoma by high temperature
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: RFA plus carrizumabExperimental treatment 1 intervention
Group B: carrizumabPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Progression-free survival
Time from patients received treatment fist time to disease progress or death
Time frame
through study completion, an average of 4 yearsSecondary outcomes
1
Objective response rate
The ratio of patients with regressive disease ,including complete response and partial response
Time frame
through study completion, an average of 4 years2
Disease control rate
The ratio of patients with regressive or stable disease, including complete response, partial response and stable disease.
Time frame
through study completion, an average of 4 years3
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
Time frame
through study completion, an average of 4 years4
Duration of response
Time from the first time of complete regression or partial regression to progressive disease or death
Time frame
through study completion, an average of 4 yearsSponsors and contacts
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Source ClinicalTrials.gov