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Monoclonal Antibodies

Yttrium-90 RadioEmbolization for Colon Cancer (iRE-C Trial)

Phase 1 & 2
Waitlist Available
Led By Pashtoon Kasi, MD, MS
Research Sponsored by Pashtoon Murtaza Kasi, MD, MS
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

iRE-C Trial Summary

This trial will study a new cancer treatment combining Yttrium-90 radioembolization with immunotherapy. The treatment will be given to people with liver-predominant, metastatic colorectal cancer that is mismatch repair proficient/microsatellite stable. The trial will evaluate the feasibility and safety of the treatment.

Eligible Conditions
  • Colon Cancer
  • Liver Metastasis
  • Liver Metastases
  • Colorectal Cancer

iRE-C Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the maximum tolerated dose (MTD) of Yttrium-90 radioembolization combined with immunotherapy durvalumab to treat liver-predominant metastatic colorectal cancer (mCRC)
Secondary outcome measures
Determine duration of response
Determine liver-specific progression free survival
Determine overall progression free survival
+4 more
Other outcome measures
Abscopal effects
Circulating tumor DNA - ctDNA - liquid biopsy correlates
Immune correlates - blood
+2 more

iRE-C Trial Design

1Treatment groups
Experimental Treatment
Group I: Y90-RE in combination with immunotherapy (durvalumab)Experimental Treatment2 Interventions
The treatment phase starts of with the immunotherapy drug (durvalumab) - "priming doses" every 2 weeks prior to patient getting mapped and ready for treatment with Y90-RadioEmbolization. Post-Y90-RE, treatment is approximately 2 months in combination with fixed doses (750 mg) of durvalumab. The number and timing of doses of durvalumab each patient will receive will depend on the dose level the patient is assigned to (range 2-5 doses of immunotherapy). A single patient will be treated per dose level until the first dose limiting toxicity (DLT) is recorded. Once the first DLT is recorded, two additional patients are treated at the same dose level and the trial reverts to a standard 3+3 design. Up to 6 patients will be treated at each dose level. The maximum tolerated dose (MTD) will be defined as the highest dose level for which at most 1 out of 6 patients experience a DLT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870

Find a Location

Who is running the clinical trial?

Pashtoon Murtaza Kasi, MD, MSLead Sponsor
AstraZenecaIndustry Sponsor
4,253 Previous Clinical Trials
288,538,165 Total Patients Enrolled
Chandrikha ChandrasekharanLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Immunotherapy With Y90-RadioEmbolization for Metastatic Colorectal Cancer
Chandrikha Chandrasekharan 2020. "Immunotherapy With Y90-RadioEmbolization for Metastatic Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04108481.
~4 spots leftby Apr 2025
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