An interventional study of Embosphere and chemotherapy drug and Polyvinyl alcohol embolization microspheres (Huihe Medical) and chemotherapy drug in Primary Liver Cancer, sponsored by Shanghai Huihe Medical Technology Co., Ltd. Status unknown at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-03-15.
Sponsored by Shanghai Huihe Medical Technology Co., Ltd · Not applicable, Interventional, and Treatment
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
1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.
This study's planned enrollment of 224 is above the median of 47 across 968 interventional studies indexed under Liver Neoplasms.
Browse Liver Neoplasms studies →Shanghai Huihe Medical Technology Co., Ltd is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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.
Device: Polyvinyl alcohol embolization microspheres (Huihe Medical) and chemotherapy drug
Device: Embosphere and chemotherapy drug
chemotherapeutic drug + embolic Embosphere;Iodide is selected according to the subject's condition
chemotherapy drug+Polyvinyl alcohol embolization microspheres (Huihe Medical);Iodide is selected according to the subject's condition
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:
Time frame: 1 month after the last TACE -mRECIST evaluation
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Shanghai Huihe Medical Technology Co., Ltd