NCT06190665 DEB-TACE With Visualable Microspheres Versus PVA Microspheres for HCC
| NCT ID | NCT06190665 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhongda Hospital |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 188 participants |
| Start Date | 2023-12-19 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 188 participants in total. It began in 2023-12-19 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will evaluate the safety and efficacy of DEB-TACE with visualable embolization microspheres versus PVA microspheres for hepatocellular carcinoma.
Eligibility Criteria
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
Contact & Investigator
Gao-Jun Teng
PRINCIPAL INVESTIGATOR
Zhongda Hospital
Frequently Asked Questions
Who can join the NCT06190665 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06190665 currently recruiting?
Yes, NCT06190665 is actively recruiting participants. Contact the research team at zhuhaidong9509@163.com for enrollment information.
Where is the NCT06190665 trial being conducted?
This trial is being conducted at Beijing, China, Nanjing, China.
Who is sponsoring the NCT06190665 clinical trial?
NCT06190665 is sponsored by Zhongda Hospital. The principal investigator is Gao-Jun Teng at Zhongda Hospital. The trial plans to enroll 188 participants.
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