Actively Recruiting
RFA Plus Carrizumab vs Carrizumab Alone for HCC
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2020-07-08
120
Participants Needed
1
Research Sites
334 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- Diagnosis of hepatocellular carcinoma confirmed by histology or cytology
- Classified as BCLC stage B or C
- ECOG Performance Status score of 0 to 2
- Child-Pugh liver function score of A or B
- Not eligible for surgical resection or liver transplantation
- No prior systemic therapy received
- At least one measurable target lesion by CT or MRI according to mRECIST criteria
- Estimated survival time of 12 weeks or more
- For patients with HBV infection, HBV-DNA less than 500 IU/mL and receiving standard antiviral treatment
- For patients with HCV infection, receiving standard antiviral treatment
- Normal function of main organs
- Signed informed consent form
You will not qualify if you...
- Diagnosis of cholangiocarcinoma, mixed hepatocarcinoma, or fibrolamellar hepatocellular carcinoma
- Presence of incurable malignant tumor within the past five years
- Local ablation, TACE, or radiotherapy within three months before enrollment
- Planned or previous 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 intake, such as inability to swallow, chronic diarrhea, or intestinal obstruction
- Gastrointestinal bleeding within the past six months
- Abdominal fistula, gastrointestinal perforation, or abdominal abscess
- Lung conditions such as fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severe lung dysfunction
- Urinary protein levels of ++ or higher on routine urine test or 24-hour urine protein ≥1.0 g
- Autoimmune disease
- Need for corticosteroid or other immunosuppressant therapy
- Use of anti-tumor vaccines or other immunostimulatory anti-tumor drugs within three months
- Allergy to monoclonal antibodies
- Pregnancy or breastfeeding
- Other conditions deeming patient unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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