Clinical Trials Directory

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UnknownNCT03969576

Drug-eluting Bead Transarterial Chemoembolisation (DEB-TACE) Versus (VS) Conventional Transarterial Chemoembolisation (cTACE) for Unresectable Hepatocellualr Carcinoma (HCC)

Efficacy and Safety of Drug-eluting Bead TACE VS Conventional TACE for Unresectable Hepatocellular Carcinoma: a Multicenter, Prospective Cohort Study

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
344 (estimated)
Sponsor
Air Force Military Medical University, China · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

this multi-center prospective cohort study is to evaluate the efficacy and the safety of drug-eluting bead TACE compared with conventional TACE in terms of objective response in unresectable HCC

Conditions

Interventions

TypeNameDescription
PROCEDUREDEB-TACEPatients in the DEB-TACE group received a maximum dose of 4 ml of DC bead (diameter 75-500 um) loaded with a maximum dose of 150 mg of anthracyclines drugs, such as doxorubicin. The anticancer agents and the diameter of DC Bead for individual patient will be selected according to the common clinical practice of each center. Treatment endpoint consisted of stasis of flow within feeding vessel(s) or completed delivery of maximum single-session dose of 150 mg doxorubicin. TACE will be repeated "on demand" according to the radiological response.
PROCEDUREcTACEPatients in the cTACE group were treated with anthracyclines, such as doxorubicin, in a mixture of lipiodol. Administration of the anticancer in oil emulsion was followed by injection of embolic materials such as gelfoam or PVA particles until complete stasis in segmental or subsegmental arterial branches. the tumor-feeding vessels should be superselected whenever possible. The anticancer agents for individual patient will be selected according to the common clinical practice of each center. TACE will be repeated "on demand" according to the radiological response.

Timeline

Start date
2020-09-15
Primary completion
2022-06-15
Completion
2022-06-15
First posted
2019-05-31
Last updated
2020-02-05

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT03969576. Inclusion in this directory is not an endorsement.