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

August 31, 2023 updated by: Gao-jun Teng, Zhongda Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age range from 18 to 80 years old (including threshold), regardless of gender；
  2. Imaging or pathology/cytology clearly diagnosed as colorectal cancer liver metastases, with complete resection of the primary lesion and no local recurrence;
  3. Researchers believe that liver metastases are not feasible or suitable, or patients refuse surgical resection；
  4. ECOG score ≤ 2 points, Child Pugh grade A or B；
  5. 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)；
  6. Voluntarily participate in this clinical trial and sign the informed consent form.

Exclusion Criteria:

  1. Patients with known severe allergy to contrast agents (iodine contrast agents, gadolinium contrast agents, etc.) or embolic materials (polyvinyl alcohol sodium acrylate copolymer) ;
  2. White blood cell count<3.0×109/L, platelet count<75×109/L，hemoglobin<70 g/L；
  3. 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;
  4. Creatinine>1.5 times the upper limit of normal value, creatinine clearance rate<30 mL/min;
  5. Prothrombin time and activated partial thromboplastin time>1.5 times the upper limit of normal value;
  6. 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)；
  7. The expected survival time is less than 3 months;
  8. 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;
  9. Pregnant and lactating women, or those who plan to conceive during the study period;
  10. Those who have participated in other intervention clinical trials within one month before the trial;
  11. The researchers believe that the subjects are intolerant and other unsuitable candidates for participating in this clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control rate (DCR) of target lesions 1 month after the last TACE treatment
Time Frame: 3 month
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
Time Frame: 3 month
The success rate of embolization techniques for target lesions
3 month
Disease control rate (DCR) of target lesions 1 month after first TACE treatment
Time Frame: 1 month
Disease control rate (DCR) of target lesions 1 month after first TACE treatment
1 month
Objective response rate (ORR)
Time Frame: 3 month
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
Time Frame: 3 month
Equipment performance evaluation: evaluation of conveying performance and degree of embolism
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongda Hospital

Investigators

  • Principal Investigator: Gao-Jun Teng, MD, Zhongda hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 10, 2023

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

August 27, 2023

First Submitted That Met QC Criteria

August 31, 2023

First Posted (Actual)

September 1, 2023

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 31, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEBIRI-TACE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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