This study will evaluate the safety and efficacy of DEB-TACE with visualable embolization microspheres versus PVA microspheres for hepatocellular carcinoma.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
188
Drug-eluting Beads Transcatheter Arterial Chemoembolization(DEB-TACE) with visualable microspheres
Drug-eluting Beads Transcatheter Arterial Chemoembolization(DEB-TACE) with polyvinyl alcohol microspheres
Peking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGZhongda Hospital,Southeast University
Nanjing, Jiangsu, China
RECRUITINGDisease control rate (DCR) for target lesions 1 month after the last TACE treatment
Target lesions were evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.
Time frame: 1 month after last TACE treatment
Visualization score of embolic area
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, 1 day, 1 month after first TACE treatment, and 1 month, 3 months, or 6 months since the last TACE treatment
Embolization success rate of target lesions
Defined as the number of successful embolizations for the target lesions / the total number of participants ×100%.
Time frame: Immediately after each TACE treatment
Equipment performance evaluation
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: From the begin to immediately after each TACE treatment
Disease control rate (DCR) for target lesions
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 3 months after the last TACE treatment
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Objective response rate(ORR)
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
Number of TACE treatments for target lesions
Totel times of TACE treatments for all target lesions
Time frame: 6 month since the last TACE treatment