Actively Recruiting
DEB-TACE With Visualable Microspheres Versus PVA Microspheres for HCC
Led by Zhongda Hospital · Updated on 2024-01-12
188
Participants Needed
2
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the safety and efficacy of DEB-TACE with visualable embolization microspheres versus PVA microspheres for hepatocellular carcinoma.
CONDITIONS
Official Title
DEB-TACE With Visualable Microspheres Versus PVA Microspheres for HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- CNLC Ia-IIIa hepatocellular carcinoma patients who require transarterial chemoembolization (TACE) and are not suitable for or refuse surgical resection, liver transplantation, or ablation
- Liver function classified as Child-Pugh A or B
- ECOG performance status score of 0 to 2
- Measurable lesions that have not been embolized (if more than 3 lesions, select the three largest as target lesions; maximum diameter of target lesions is 10 cm or less)
- Agree to participate and voluntarily sign the informed consent form
You will not qualify if you...
- Target lesions already embolized or requiring concomitant ablation or radiotherapy after TACE
- Diffuse liver tumor or extrahepatic metastasis with expected survival less than 6 months
- Sepsis or multiple organ dysfunction
- Severe liver dysfunction (Child-Pugh C) or severe renal dysfunction (blood creatinine greater than 2 mg/dL)
- Significant uncorrectable reductions in white blood cells, platelets, or hemoglobin (white blood cells less than 3.0 x 10^9/L, platelets less than 50 x 10^9/L, hemoglobin less than 60 g/L), excluding splenomegaly or chemotherapy-induced bone marrow suppression
- Uncorrectable coagulation dysfunction (prothrombin time prolonged by more than 3 seconds above normal)
- Severe infection (white blood cells more than 5 times the upper limit of normal)
- Complete embolization of the main portal vein by tumor thrombus without collateral blood supply
- Risk of ectopic embolization due to uncorrected arteriovenous or portal venous fistula in arteries supplying target lesions
- Vascular anatomy obstruction or vasospasm affecting catheter placement or embolic agent injection
- Known allergy to iodine-containing contrast agents, polyvinyl alcohol materials, or anthracycline chemotherapy drugs
- Pregnant or lactating women
- Participation in other clinical trials
- Any condition deemed unsuitable for participation by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
2
Zhongda Hospital，Southeast University
Nanjing, Jiangsu, China, 210009
Actively Recruiting
Research Team
H
Hai-Dong Zhu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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