Actively Recruiting
Radiofrequency Ablation Plus Carrizumab vs Carrizumab Alone for Moderate or Advanced Hepatocellular Carcinoma: A Real World Study
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2020-07-08
120
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether patients with advanced hepatocellular carcinoma (HCC), a type of liver cancer, can benefit more from a combination of radiofrequency ablation (RFA) and the PD-1 immunosuppressant drug carrizumab compared to carrizumab alone. This study is a phase 2 trial that involves 120 patients divided into two groups to assess progression-free survival (PFS) and other outcomes. The research aims to understand which treatment approach may better control tumor growth in this patient population. The study compares two treatment methods: one group receives RFA combined with carrizumab, where RFA uses heat to destroy cancer cells, and the other group receives carrizumab alone. Patients in each group are monitored over an average of four years. The study is double-blinded and non-randomized, meaning neither patients nor doctors know who is receiving which treatment during the trial. Participants will undergo regular assessments including imaging scans like CT or MRI to measure tumor response, clinical evaluations, and laboratory tests. Researchers will track progression-free survival as the main outcome and also measure response rates, disease control, overall survival, and duration of response throughout the study. Safety and organ function are monitored, and the total participation time averages about four years from the start of treatment to study completion.
CONDITIONS
Brief Title
RFA Plus Carrizumab vs Carrizumab Alone for HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 18 to 75 years
- Diagnosed with hepatocellular carcinoma confirmed by histology or cytology
- BCLC stage B or C
- ECOG performance status score between 0 and 2
- Child-Pugh liver function score of A or B
- Not suitable for surgical resection or liver transplantation
- No prior systemic therapy for hepatocellular carcinoma
- At least one measurable tumor on CT or MRI according to mRECIST criteria
- Estimated survival of at least 12 weeks
- Patients with HBV infection must have HBV-DNA less than 500 IU/mL and be on standard antiviral treatment
- Patients with HCV infection must receive standard antiviral treatment
- Normal function of major organs
- Signed informed consent
You will not qualify if you...
- Diagnosis of cholangiocarcinoma, mixed hepatocarcinoma, or fibrolamellar hepatocellular carcinoma
- Incurable malignant tumor within the past five years
- Received local ablation, TACE, or radiotherapy within 3 months before enrollment
- Planned or prior organ or bone marrow transplantation
- Uncontrolled ascites, hepatic encephalopathy, or esophageal and gastric varices
- Hypertension not controlled by medication
- Type II myocardial ischemia, myocardial infarction, or uncontrolled arrhythmia
- Conditions affecting oral drug absorption such as inability to swallow, chronic diarrhea, or intestinal obstruction
- Gastrointestinal bleeding within 6 months
- Abdominal fistula, gastrointestinal perforation, or abdominal abscess
- Lung diseases including fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severe lung dysfunction
- Urinary protein ≥++ on routine urine test or ≥1.0 g in 24-hour urine
- Autoimmune disease
- Need for corticosteroid or other immunosuppressant therapy
- Received anti-tumor vaccine or other immunostimulant anti-tumor drugs within 3 months
- Allergy to monoclonal antibodies
- Pregnant or breastfeeding females
- Other conditions making the patient unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to an average of 4 years or until disease progression or discontinuation
Participants receive radiofrequency ablation plus carrizumab or carrizumab alone as treatment for hepatocellular carcinoma.
Visits as needed for treatment administration and monitoring
Trial Site Locations
Total: 1 location
1
the Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
Z
Zhe Tang, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here