Spots Global Cancer Trial Database for Safety and Efficacy of Polyvinyl Alcohol Sodium Acrylate Embolization Microspheres for CRLM

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Trial Identification

Brief Title: Safety and Efficacy of Polyvinyl Alcohol Sodium Acrylate Embolization Microspheres for CRLM

Official Title: A Prospective, Multicenter, Randomized Controlled Clinical Trial on the Safety and Efficacy of Polyvinyl Alcohol Sodium Acrylate Embolization Microspheres for Transcatheter Arterial Chemoembolization of Colorectal Cancer Liver Metastases

Study ID: NCT06021015

Conditions

Colorectal Cancer Liver Metastasis

Interventions

Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres（Unipearls®）

Irinotecan and HepaSphere Microspheres

Study Description

Brief Summary: 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.

Detailed Description: 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.