NCT06021015

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Zhongda Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer Liver Metastasis

Interventions

Type	Name	Description
DEVICE	Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres（Unipearls®）	Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres（Unipearls®）
DEVICE	Irinotecan and HepaSphere Microspheres	Irinotecan and HepaSphere Microspheres

Timeline

• Start date: 2023-09-10
• Primary completion: 2025-06-30
• Completion: 2025-12-31
• First posted: 2023-09-01
• Last updated: 2023-09-01