NCT06190665Recruiting
DEB-TACE With Visualable Microspheres Versus PVA Microspheres for HCC
DEB-TACE With Visualable Microspheres Versus PVA Microspheres for Hepatocellular Carcinoma: a Prospective, Multicenter, Randomized Controlled, Non-inferior Trial
Source: ClinicalTrials.gov · Last updated 12 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study will evaluate the safety and efficacy of DEB-TACE with visualable embolization microspheres versus PVA microspheres for hepatocellular carcinoma.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 188 (estimated)
- First submitted
- 19 Dec 2023
- Start date
- 19 Dec 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Zhongda Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06190665
What you commit to
- Study type: Interventional
- Planned participants: 188
- From 19 Dec 2023 to the primary completion date, 31 Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Target lesions were embolized, or will require concomitant ablation or radiotherapy after TACE treatment(s)
Other illness
- With risk of ectopic embolization (uncorrected arteriovenous fistula or portal venous fistula) in the target lesion supplying arteries
- Known allergy to iodine-containing contrast agents, polyvinyl alcohol materials or anthracycline t ochemotherapy drugs
Lab values
- 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
Other
- With diffuse liver tumor or extrahepatic metastasis, expected survival \<6 months With sepsis or multiple organ dysfunction
- Angiography shows vascular anatomy obstruction or vasospasm that will affect the catheter placemenr embolic agent injection
- Pregnant or lactating women
- Patients who are participating in other trial(s)
- Unsuitable for participation in this trial deemed by the researchers
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Zhongda Hospital Southeast University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.