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To evaluate the safety and efficacy of polyvinyl alcohol embolization microspheres developed and manufactured by Shanghai Huihe Medical Technology Co., LTD. (hereinafter referred to as Huihe Medical) for transarterial chemoembolization of primary liver cancer using a prospective, multi-center, randomized controlled method
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polyvinyl alcohol embolization microspheres (Huihe Medical) and chemotherapy drug | Experimental | The experimental group received chemotherapy drug + polyvinyl alcohol embolized microspheres (Huihe Medical) for target lesion TACE (Trans-Arterial Chemoembolization)treatment.Experimental group and control group were selected to use iodide oil according to the condition of subjects. |
|
| Embosphere and chemotherapy drug | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embosphere and chemotherapy drug | Device | chemotherapeutic drug + embolic Embosphere;Iodide is selected according to the subject's condition |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) 1 month after the last TACE -mRECIST evaluation | Target lesions of subjects were treated with TACE for 1-3 times as needed, and the last evaluation of target lesions before enrollment was used as baseline tumor evaluation. One month after the last TACE, all subjects underwent plain CT and enhanced MRI examinations, which were compared with the baseline of target lesions. The efficacy was evaluated according to the mRECIST (Modified Response Evaluation Criteria in Solid Tumors)for the treatment of solid tumors in target foci. For example, multiple tumor foci were embolized at the same time, and the two largest target foci were selected as the evaluation foci: | 1 month after the last TACE -mRECIST evaluation |
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Inclusion Criteria:
Exclusion Criteria:
16. People with known severe allergy to contrast agents, iodine contrast agents or embolic materials; 17. Pregnant/lactating women, or those who plan to give birth; 18. Patients who are participating in clinical trials of other drugs or devices and have not been in the group or have been in the group for less than 1 month; 19. Persons without the ability to make independent decisions or with mental illness; 20. Other patients deemed unsuitable for this clinical trial by the investigator;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Huihe Healthcare Tecnology Co.,Ltd. | Shanghai | Shanghai Municipality | 201615 | 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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| Polyvinyl alcohol embolization microspheres (Huihe Medical) and chemotherapy drug | Device | chemotherapy drug+Polyvinyl alcohol embolization microspheres (Huihe Medical);Iodide is selected according to the subject's condition |
|
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |