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

Primary Purpose

Colorectal Cancer Liver Metastasis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres(Unipearls®)
Irinotecan and HepaSphere Microspheres
Sponsored by
Zhongda Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer Liver Metastasis focused on measuring colorectal cancer, liver metastasis, embolization microspheres, efficacy, safety, transcatheter arterial chemoembolization

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental group

    Control group

    Arm Description

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

    Irinotecan and HepaSphere Microspheres

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Success rate
    The success rate of embolization techniques for target lesions
    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
    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
    Equipment performance evaluation
    Equipment performance evaluation: evaluation of conveying performance and degree of embolism

    Full Information

    First Posted
    August 27, 2023
    Last Updated
    August 31, 2023
    Sponsor
    Zhongda Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06021015
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 10, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Zhongda Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer Liver Metastasis
    Keywords
    colorectal cancer, liver metastasis, embolization microspheres, efficacy, safety, transcatheter arterial chemoembolization

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    72 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres(Unipearls®)
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Irinotecan and HepaSphere Microspheres
    Intervention Type
    Device
    Intervention Name(s)
    Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres(Unipearls®)
    Intervention Description
    Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres(Unipearls®)
    Intervention Type
    Device
    Intervention Name(s)
    Irinotecan and HepaSphere Microspheres
    Intervention Description
    Irinotecan and HepaSphere Microspheres
    Primary Outcome Measure Information:
    Title
    Disease control rate (DCR) of target lesions 1 month after the last TACE treatment
    Description
    Disease control rate (DCR) of target lesions 1 month after the last TACE treatment
    Time Frame
    3 month
    Secondary Outcome Measure Information:
    Title
    Success rate
    Description
    The success rate of embolization techniques for target lesions
    Time Frame
    3 month
    Title
    Disease control rate (DCR) of target lesions 1 month after first TACE treatment
    Description
    Disease control rate (DCR) of target lesions 1 month after first TACE treatment
    Time Frame
    1 month
    Title
    Objective response rate (ORR)
    Description
    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
    Title
    Equipment performance evaluation
    Description
    Equipment performance evaluation: evaluation of conveying performance and degree of embolism
    Time Frame
    3 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jian Lu, MD
    Phone
    +8615850654644
    Email
    lujian43307131@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gao-Jun Teng, MD
    Organizational Affiliation
    Zhongda Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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