Actively Recruiting
Single-arm, Prospective Clinical Study of TAE+HAIC Combined With Camrelizumab and Apatinib in the Treatment of Advanced Hepatocellular Carcinoma With High Tumor Load
Led by Fujian Medical University · Updated on 2024-04-17
57
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combination treatment involving TAE (transarterial embolization), HAIC (hepatic arterial infusion chemotherapy), camrelizumab, and apatinib for advanced liver cancer with a high tumor burden. This phase 2, single-arm, prospective, multicenter study aims to explore the safety and effectiveness of this new regimen in patients with advanced hepatocellular carcinoma. The study is designed to provide important data for future larger clinical trials and to identify a potential new treatment approach for this condition. The treatment involves arterial infusion of TAE and HAIC combined with intravenous camrelizumab and oral apatinib. Camrelizumab is given intravenously at 200 mg every three weeks, starting one day before arterial infusion treatments. The TAE and HAIC treatments consist of iodized oil and chemotherapy drugs infused into the liver arteries on the second day of each cycle. Oral apatinib is taken daily after discharge, with a pause for three days before the next cycle. This regimen is given in cycles, and the study focuses on patients with a high tumor load. Participants will be monitored through various assessments including imaging scans to measure tumor response, blood tests to evaluate organ function, and questionnaires to track side effects. The primary outcome is the objective response rate at one year. Secondary outcomes include disease control rate, progression-free survival, tumor progression time, overall survival over three years, and adverse events. Participants are expected to be followed for safety and efficacy throughout the study period, with careful evaluation of liver function and tumor status.
CONDITIONS
Brief Title
A Study of TAE+HAIC Combined With Camrelizumab and Apatinib in the Treatment of Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily joined the study with good compliance and written informed consent
- Age between 18 and 80 years, any gender
- Confirmed diagnosis of hepatocellular carcinoma with pathological results
- At least one measurable lesion of 10mm or larger (or malignant lymph node 15mm or larger) by RECIST 1.1 criteria
- No prior systemic treatment received
- CNLC stage between Ia and IIb
- High tumor load defined by criteria including tumor number and size or portal vein involvement
- Child-Pugh liver function grade A or B (score 5-8)
- ECOG performance status 0-1
- Expected survival of at least 12 weeks
- If active hepatitis B infection: HBV-DNA ≤2000 or antiviral therapy started before treatment
- Adequate major organ function including blood counts, liver enzymes, and kidney function
- Women of childbearing age must have negative pregnancy test and agree to contraception; men must agree to contraception during and after treatment
You will not qualify if you...
- Pregnant or breastfeeding women
- Autoimmune diseases, organ or stem cell transplant history, or other active malignancies except certain cured cancers
- Mental illness or consciousness disorders interfering with treatment
- Participation in other clinical trials within 3 months
- Local treatments like surgery or radiation within 1 month prior
- Recent thrombotic or embolic events within 6 months (excluding portal vein thrombosis)
- Use of immunosuppressants or high-dose steroids within 14 days before enrollment
- Recent esophageal or fundus varices bleeding within 1 month
- Severe bleeding risks or uncorrectable coagulation problems
- Refractory ascites or severe fluid imbalance
- Active infections, especially biliary inflammation
- Severe failure of major organs like liver, kidney, heart, lung, or brain
- Previous use of PD-1 antibodies or similar targeted drugs
- Uncontrolled hypertension despite medication
- Significant cardiovascular diseases or heart failure
- Positive urinary protein tests indicating kidney issues
- Inability to swallow pills or malabsorption
- Other diseases judged unsafe by investigators
- Refusal to undergo biopsy for diagnosis confirmation
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.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive arterial infusion treatment with TAE+HAIC combined with camrelizumab and oral apatinib as part of the study regimen.
Visits every 3 weeks for camrelizumab infusion and arterial infusion treatment, with daily oral apatinib between cycles
Trial Site Locations
Total: 1 location
1
Xinhua Chen
Fuzhou, China
Actively Recruiting
Research Team
Y
Yiping Chen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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