Selective Internal Radiation Therapy With 90Y Resin Micropheres for Refractory Colorectal Cancer Liver Metastases

NCT04491929 | Recruiting DMC

• 1 other identifier: 1-10-72-111-20
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Observational, feasibility study investigating biological aspects in patients with liver metastasis from colorectal cancer undergoing treatment with SIRT, by translational analysis of biological samples.

Conditions

Liver Metastasis Colon Cancer

Keywords

Liver metastasis Colon Cancer; Circulating Tumour DNA; Selective Internal Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• Feasibility and translational analysis

  Investigating potential prognostic and predictive markers for efficacy by molecular characteristics and mutational analysis

  When 5 patients are included, the blood samples will be analysed for explorative analysis (expected after the first year). In all we expect to include 30 patients if positive results.

Secondary Outcomes (3)

• Response Rate

  6 months

• Progression Free Survival

  3 years

• Overall Survival

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients with metastatic colorectal cancer with chemorefractory liver dominant disease. Patients are found not eligible for surgical resection, RFA or SBRT by a multidisciplinary tumour board (MDT), and considered candidates for SIRT treatment in order to obtain disease control or resectability.

You may qualify if:

• Diagnosis of metastatic colorectal adenocarcinoma with liver dominant disease
• Diagnosis of liver metastasis may be made by histo- or cyto-pathology, or by clinical and imaging criteria.
• The Liver metastasis are not eligible for resection, RFA or SBRT
• All patients must be off all chemotherapeutic regimens for 14 days prior to SIRT treatment
• All patients must be off vascular endothelial growth factor inhibitors for 6 weeks prior to SIRT treatment
• Progressive disease, severe intolerance during or following all standard lines of chemo-therapy
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Age 18 years or older
• Able to understand written information
• Consent to samples for translational research

You may not qualify if:

• Pretherapeutic work-up procedure with Tc-99m macroaggregated albumin (MAA) scintigraphy showing extrahepatic foci in GI-tract
• Evidence of any detectable Tc-99m macroaggregated albumin deposition in the stomach or duodenum, after application of established angiographic techniques to stop such deposition
• Previous radiation therapy to the lungs and/or to the upper abdomen overlapping with dose to the liver at interventionist´s decision
• Lung shunt greater than 20% or \> 30 Gray radiation absorbed dose to the lungs, at estimated by Tc-99m-MAA
• Pregnancy
• Symptomatic lung disease precluding SIRT at interventionist´s decision
• Active uncontrolled infection
• Any pre-treatment laboratory findings within 30 days of treatment demonstrating: alanine aminotransferase level greater than 5 times upper normal limit and/or serum bilirubin greater than 2 mg/dl (\>34 umol/l)
• Current or previously evidence of ascites on CT-scan or physical examination
• Tumour volume greater than 50% of liver volume
• Conditions precluding translational samples

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Department of Oncology, Aarhus University Hospital

Aarhus N, Danmark, 8200, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

Study Officials

• Louise B Callesen

  Experimental Clinical Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Louise B Callesen, MD

CONTACT

+4578462535; louicall@rm.dk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: July 30, 2020
• Study Start: November 1, 2020
• Primary Completion: February 28, 2026
• Study Completion (Estimated): September 30, 2028
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)