An interventional study of Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres(Unipearls®) and Irinotecan and HepaSphere Microspheres in Colorectal Cancer Liver Metastasis, sponsored by Zhongda Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-01.
Sponsored by Zhongda Hospital · Not applicable, Interventional, and Treatment
This study is a prospective, multicenter, randomized controlled clinical trial to evaluate the safety and efficacy of polyvinyl alcohol sodium acrylate embolization microspheres and HepaSphere Microspheres loaded with irinotecan for the treatment of colorectal cancer with hepatic metastases through arterial chemoembolization.
This study is a prospective, multicenter, randomized controlled clinical trial. Seventy-two patients with colorectal cancer liver metastases that are not feasible or suitable for surgical resection will be enrolled in this study. The experimental group received transcatheter arterial chemoembolization (TACE) treatment with polyvinyl alcohol sodium acrylate embolization microspheres loaded with 100mg irinotecan and the control group received TACE treatment with HepaSphere Microspheres loaded with 100mg irinotecan. All patients received 1-2 TACE treatment as needed. The primary end point of this study is disease control rate (DCR) of target lesions 1 month after the last TACE treatment.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 72 is close to the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
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Exclusion Criteria:
Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres(Unipearls®)
Device: Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres(Unipearls®)
Irinotecan and HepaSphere Microspheres
Device: Irinotecan and HepaSphere Microspheres
Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres(Unipearls®)
Irinotecan and HepaSphere Microspheres
Disease control rate (DCR) of target lesions 1 month after the last TACE treatment
Disease control rate (DCR) of target lesions 1 month after the last TACE treatment
Time frame: 3 month
Success rate
The success rate of embolization techniques for target lesions
Time frame: 3 month
Disease control rate (DCR) of target lesions 1 month after first TACE treatment
Disease control rate (DCR) of target lesions 1 month after first TACE treatment
Time frame: 1 month
Objective response rate (ORR)
Objective response rate (ORR) of target lesions 1 month after the first TACE treatment and 1 month after the last TACE treatment
Time frame: 3 month
Equipment performance evaluation
Equipment performance evaluation: evaluation of conveying performance and degree of embolism
Time frame: 3 month
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Zhongda Hospital