UnknownNot Applicable

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

72 participantsStarted 2023-09-10

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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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;

What they're measuring

Disease control rate (DCR) of target lesions 1 month after the last TACE treatment

Timeframe: 3 month

Trial details

NCT IDNCT06021015

SponsorZhongda Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-30

Contact for this trial

Jian Lu, MD

+8615850654644 lujian43307131@126.com

View on ClinicalTrials.gov More Colorectal Cancer Liver Metastasis trials