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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Colorectal Cancer Liver Metastasis

Intervention / Treatment
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* Device: Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres（Unipearls®）
* Device: Irinotecan and HepaSphere Microspheres


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age range from 18 to 80 years old (including threshold), regardless of gender； Imaging or pathology/cytology clearly diagnosed as colorectal cancer liver metastases, with complete resection of the primary lesion and no local recurrence; Researchers believe that liver metastases are not feasible or suitable, or patients refuse surgical resection； ECOG score ≤ 2 points, Child Pugh grade A or B； At least one measurable liver metastasis with a diameter greater than 1 cm without embolization treatment (the maximum diameter of the target lesion is less than 10 cm)； Voluntarily participate in this clinical trial and sign the informed consent form. Exclusion Criteria: Patients with known severe allergy to contrast agents (iodine contrast agents, gadolinium contrast agents, etc.) or embolic materials (polyvinyl alcohol sodium acrylate copolymer) ; White blood cell count<3.0×109/L, platelet count<75×109/L，hemoglobin<70 g/L； Total bilirubin>2 times the upper limit of normal value, Alanine transaminase (ALT) or aspartate aminotransferase (AST) >5 times the upper limit of normal value, Alkaline phosphatase>2.5 times the upper limit of normal value, albumin<30 g/L; Creatinine>1.5 times the upper limit of normal value, creatinine clearance rate<30 mL/min; Prothrombin time and activated partial thromboplastin time>1.5 times the upper limit of normal value; Target lesion blood supply artery cannot undergo TACE treatment (the blood supply artery is too thin，vasospasm or suspected vasospasm，peripheral vascular resistance of the blood supply artery hinders the entry of embolic microspheres into the lesion site，severe Atherosclerosis, etc) or there is a risk of embolism (collateral vascular pathway endangers normal areas, etc)； The expected survival time is less than 3 months; Patients who have received embolization therapy for the target lesion or undergo the first TACE treatment for the target lesion after enrollment and require combined ablation/radiotherapy; Pregnant and lactating women, or those who plan to conceive during the study period; Those who have participated in other intervention clinical trials within one month before the trial; The researchers believe that the subjects are intolerant and other unsuitable candidates for participating in this clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres（Unipearls®） | Device: Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres（Unipearls®）<br>* Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres（Unipearls®）<br>|
| Active Comparator: Control group<br>Irinotecan and HepaSphere Microspheres | Device: Irinotecan and HepaSphere Microspheres<br>* Irinotecan and HepaSphere Microspheres<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate | The success rate of embolization techniques for target lesions | 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 | 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 | 3 month | 
| Equipment performance evaluation | Equipment performance evaluation: evaluation of conveying performance and degree of embolism | 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, liver metastasis, embolization microspheres, efficacy, safety, transcatheter arterial chemoembolization