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

NCT06021015 | Unknown DMC

• 1 other identifier: DEBIRI-TACE
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Cancer Liver Metastasis

Keywords

colorectal cancer; liver metastasis; embolization microspheres; efficacy; safety; transcatheter arterial chemoembolization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Success rate

  3 month

• Disease control rate (DCR) of target lesions 1 month after first TACE treatment

  1 month

• Objective response rate (ORR)

  3 month

• Equipment performance evaluation

  3 month

Study Arms (2)

Experimental group

EXPERIMENTAL

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

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

Control group

ACTIVE COMPARATOR

Irinotecan and HepaSphere Microspheres

Device: Irinotecan and HepaSphere Microspheres

Interventions

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

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

Experimental group

Irinotecan and HepaSphere Microspheres DEVICE

Irinotecan and HepaSphere Microspheres

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongda Hospital: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Gao-Jun Teng, MD

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Lu, MD

CONTACT

+8615850654644; lujian43307131@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 27, 2023
• First Posted: September 1, 2023
• Study Start: September 10, 2023
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share