DEB-TACE with visualable microspheres
DeviceDrug-eluting Beads Transcatheter Arterial Chemoembolization(DEB-TACE) with visualable microspheres
NCT Number: NCT06190665
This study will evaluate the safety and efficacy of DEB-TACE with visualable embolization microspheres versus PVA microspheres for hepatocellular carcinoma.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Peking University First Hospital, Beijing, Beijing Municipality, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Drug-eluting Beads Transcatheter Arterial Chemoembolization(DEB-TACE) with visualable microspheres
Drug-eluting Beads Transcatheter Arterial Chemoembolization(DEB-TACE) with polyvinyl alcohol microspheres
Time frame: 1 month after last TACE treatment
Target lesions were evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.
Time frame: Immediately, 1 day, 1 month after first TACE treatment, and 1 month, 3 months, or 6 months since the last TACE treatment
Evaluation will be performed, based on CBCT images after the first TACE treatment, or CT plain images after the last TACE treatment as follow: 3 points: dense imaging (imaging area >75% of tumor area); 2 points: mixed imaging (imaging area 25%-75% of tumor area); 1 point: weak imaging (imaging area <25% of tumor area); 0 point: not visible (no imaging in the tumor area).
Time frame: Immediately after each TACE treatment
Defined as the number of successful embolizations for the target lesions / the total number of participants ×100%.
Time frame: From the begin to immediately after each TACE treatment
Includes,the visualization performance of the microspheres on the fluoroscopy or cone-beam CT imaging; whether the microspheres can be easy pushed and pass through the catheter smoothly; whether the micro-catheter will be blocked during the process of pushing and releasing?
Time frame: 1 month after the first TACE treatment, and 3 months after the last TACE treatment
Target lesions will be evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST), based on the enhanced CT/MRI (liver) images.
Time frame: 1 month after the first TACE treatment and 1 month, 3 months since the last TACE treatment
Target lesions will be evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST), based on the enhanced CT/MRI (liver) images.
Time frame: 6 month since the last TACE treatment
Totel times of TACE treatments for all target lesions
Contact information is provided by the study sponsor or research team.
Zhongda Hospital
Other
DEB-TACE With Visualable Microspheres Versus PVA Microspheres for Hepatocellular Carcinoma: a Prospective, Multicenter, Randomized Controlled, Non-inferior Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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