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Clinical Trials/NCT06190665
NCT06190665RecruitingNot Applicable

DEB-TACE With Visualable Microspheres Versus PVA Microspheres for Hepatocellular Carcinoma: a Prospective, Multicenter, Randomized Controlled, Non-inferior Trial

Zhongda Hospital2 sites in 1 country188 target enrollmentStarted: December 19, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
188
Locations
2
Primary Endpoint
Disease control rate (DCR) for target lesions 1 month after the last TACE treatment
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 carcinoma.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Disease control rate (DCR) for target lesions 1 month after the last TACE treatment

Time Frame: 1 month after last TACE treatment

Target lesions were evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.

Secondary Outcomes

  • Visualization score of embolic area(Immediately, 1 day, 1 month after first TACE treatment, and 1 month, 3 months, or 6 months since the last TACE treatment)
  • Disease control rate (DCR) for target lesions(1 month after the first TACE treatment, and 3 months after the last TACE treatment)
  • Number of TACE treatments for target lesions(6 month since the last TACE treatment)
  • Equipment performance evaluation(From the begin to immediately after each TACE treatment)
  • Objective response rate（ORR）(1 month after the first TACE treatment and 1 month, 3 months since the last TACE treatment)
  • Embolization success rate of target lesions(Immediately after each TACE treatment)

Investigators

Sponsor
Zhongda Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gao-jun Teng

Dean

Zhongda Hospital

Study Sites (2)

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DEB-TACE With Visualable Microspheres... | Clinical Trial