Status:
UNKNOWN
Safety and Efficacy of Polyvinyl Alcohol Sodium Acrylate Embolization Microspheres for CRLM
Lead Sponsor:
Zhongda Hospital
Conditions:
Colorectal Cancer Liver Metastasis
Eligibility:
All Genders
18-80 years
Phase:
NA
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 Microsp...
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06021015
Start Date
September 10 2023
End Date
December 31 2025
Last Update
September 1 2023
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