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To verify the safety and efficacy of TACE withThermosensitive Nanogel Embolic Agent for HCC.
This is a prospective, multicenter, randomized controlled, non-inferiority design trial. Participants who meet the criteria will be randomly assigned into the experimental group or the control group,with a ratio of 1:1. In the experimental group the Thermosensitive Nanogel Embolic Agent will be used in the TACE procedure, while in the control group the Embosphere microspheres will be used. The primary endpoint is disease control rate of the target lesions at 1 month after the last TACE treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TACE with Thermosensitive Nanogel Embolic Agent | Experimental | Equipment: Thermosensitive Nanogel Embolic Agent |
|
| TACE with Embosphere Microspheres | Active Comparator | Equipment: Embosphere Microspheres |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermosensitive Nanogel Embolic Agent | Device | Thermosensitive Nanogel Embolic Agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | Probability of target lesion control, evaluated by the investigator and independent image review committee respectively (mRECIST). | One month after the last TACE |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of target lesion embolization | Success rate of target lesion embolization, evaluated by the investigator and independent image review committee respectively. | One month after the last TACE |
| Objective response rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lei Zhang, M.D. | Contact | +86 13770106862 | llei589@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Gao-Jun Teng, M.D. | Zhongda Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gao-Jun Teng | Recruiting | Nanjing | 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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Objective response rate of target lesions, evaluated by the investigator and independent image review committee respectively (mRECIST).
| One month after the last TACE treatment |
| Disease control rate (DCR) | Probability of target lesion control, evaluated by the investigator and independent image review committee respectively (mRECIST). | Three and six months after the first TACE |
| Equipment performance evaluation | (Intraoperative imaging ability, microcatheter delivery capacity) evaluated by the investigator. | One month after the first TACE |
| Adverse events | Rate of adverse events, evaluated by the investigator (CTACE 5.0) | Up to 24 months |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |