|

DEB-TACE With Visualable Microspheres Versus PVA Microspheres for HCC

RECRUITINGN/ASponsored by Zhongda Hospital
Actively Recruiting
PhaseN/A
SponsorZhongda Hospital
Started2023-12-19
Est. completion2025-12-31
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted

Summary

This study will evaluate the safety and efficacy of DEB-TACE with visualable embolization microspheres versus PVA microspheres for hepatocellular carcinoma.

Eligibility

Age: 18 Years – 80 YearsHealthy volunteers accepted
Inclusion Criteria:

* 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 Criteria:

* 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

Conditions4

CancerHepatocellular CarcinomaLiver CancerLiver Disease

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.