Status:
RECRUITING
DEB-TACE With Visualable Microspheres Versus PVA Microspheres for HCC
Lead Sponsor:
Zhongda Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This study will evaluate the safety and efficacy of DEB-TACE with visualable embolization microspheres versus PVA microspheres for hepatocellular carcinoma.
Detailed Description
This study is a prospective, multicenter, randomized controlled, non-inferior trial to evaluate the safety and efficacy of DEB-TACE with visualable microspheres or PVA microspheres for hepatocellular ...
Eligibility Criteria
Inclusion
- CNLC Ia-IIIa HCC patients who require transarterial chemoembolization (TACE) and are not suitable for or refuse surgical resection, liver transplantation, or ablation Liver function classification of Child-Pugh A or B
- ECOG PS score of 0-2
- With measurable lesions that had not been embolized (if there are more than 3 lesions, select the three largest lesions as target lesions, and the maximum diameter of target lesion is ≤10cm)
- Agree to participate in this trial and voluntarily sign the informed consent form
Exclusion
- Target lesions were embolized, or will require concomitant ablation or radiotherapy after TACE treatment(s)
- With diffuse liver tumor or extrahepatic metastasis, expected survival \<6 months With sepsis or multiple organ dysfunction
- Severe liver dysfunction (Child-Pugh C) , or severerenal dysfunction (blood creatinine \>2 mg/dL)
- Significant reductions in white blood cells or platelets (white blood cells \<3.0×10\^9/L, platelets \<50×10\^9/L, hemoglobin\<60g/L) that cannot be corrected (except splenomegaly or chemotherapy-induced bone marrow suppression) Uncorrectable coagulation dysfunction (PT prolonged by \>3 seconds above the upper limit of normal)
- With severe infection (\>5 times the upper limit of normal white blood cells) The main portal vein was completely embolized by tumor thrombus without collateral blood supply
- With risk of ectopic embolization (uncorrected arteriovenous fistula or portal venous fistula) in the target lesion supplying arteries
- Angiography shows vascular anatomy obstruction or vasospasm that will affect the catheter placemenr embolic agent injection
- Known allergy to iodine-containing contrast agents, polyvinyl alcohol materials or anthracycline t ochemotherapy drugs
- Pregnant or lactating women
- Patients who are participating in other trial(s)
- Unsuitable for participation in this trial deemed by the researchers
Key Trial Info
Start Date :
December 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT06190665
Start Date
December 19 2023
End Date
December 31 2026
Last Update
January 12 2024
Active Locations (2)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
2
Zhongda Hospital，Southeast University
Nanjing, Jiangsu, China, 210009