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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.