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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06021015
Other study ID # DEBIRI-TACE
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 10, 2023
Est. completion date December 31, 2025

Study information

Verified date August 2023
Source Zhongda Hospital
Contact Jian Lu, MD
Phone +8615850654644
Email lujian43307131@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 72
Est. completion date December 31, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Zhongda Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Success rate The success rate of embolization techniques for target lesions 3 month
Secondary 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
Secondary 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
Secondary Equipment performance evaluation Equipment performance evaluation: evaluation of conveying performance and degree of embolism 3 month
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