Actively Recruiting
A Study of TAE+HAIC Combined With Camrelizumab and Apatinib in the Treatment of Advanced Hepatocellular Carcinoma
Led by Fujian Medical University · Updated on 2024-04-17
57
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of TAE+HAIC combined with camrelizumab and apatinib in the treatment of advanced liver cancer with high tumor load
CONDITIONS
Official 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 agree to participate and provide written informed consent
- Age between 18 and 80 years, male or female
- Confirmed diagnosis of hepatocellular carcinoma with pathological results based on established guidelines
- At least one measurable lesion meeting RECIST 1.1 criteria
- No prior systemic treatment received
- CNLC stage Ia to IIb
- Meet criteria for high tumor burden based on tumor number and size or portal vein involvement
- Child-Pugh liver function grade A or B (5-8 points)
- ECOG performance status score of 0 or 1
- Expected survival of at least 12 weeks
- For patients with active hepatitis B infection, HBV-DNA levels controlled before treatment
- Adequate major organ function based on blood counts and biochemistry
- Women of childbearing potential must have a negative pregnancy test and agree to contraception; men must agree to contraception during and after the trial
You will not qualify if you...
- Pregnant or breastfeeding women
- Autoimmune diseases, organ or stem cell transplantation, or other active malignancies (except certain cured skin or cervical cancers)
- Mental illness or inability to cooperate with treatment
- Participation in other clinical trials within past 3 months
- Local treatments such as surgery or radiation within past month
- Recent thrombotic or embolic events within 6 months (except portal vein thrombosis)
- Use of immunosuppressants or high-dose steroids within 14 days before enrollment
- Recent esophageal varices bleeding within 1 month
- Severe bleeding disorders 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
- Prior use of targeted drugs or PD-1 inhibitors
- Uncontrolled hypertension despite medication
- Serious cardiovascular diseases or reduced heart function
- Significant proteinuria
- Conditions affecting swallowing or absorption
- Other diseases that may endanger safety or interfere with study
- Refusal to undergo biopsy for diagnosis confirmation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Xinhua Chen
Fuzhou, China
Actively Recruiting
Research Team
Y
Yiping Chen
CONTACT
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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