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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visualable microspheres | Experimental | DEB-TACE with visualable microspheres |
|
| PVA microspheres | Active Comparator | DEB-TACE with polyvinyl alcohol microspheres |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEB-TACE with visualable microspheres | Device | Drug-eluting Beads Transcatheter Arterial Chemoembolization(DEB-TACE) with visualable microspheres |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease 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. | 1 month after last TACE treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hai-Dong Zhu | Contact | +86-25-83272121 | zhuhaidong9509@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Gao-Jun Teng | Zhongda Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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DEB-TACE with visualable microspheres or PVA microspheres
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| DEB-TACE with PVA microspheres | Device | Drug-eluting Beads Transcatheter Arterial Chemoembolization(DEB-TACE) with polyvinyl alcohol microspheres |
|
| 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%. | 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? | 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. | 1 month after the first TACE treatment, and 3 months after the last TACE treatment |
| 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. | 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 | 6 month since the last TACE treatment |
| Zhongda Hospital,Southeast University | Recruiting | Nanjing | Jiangsu | 210009 | China |
|
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |