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Immunotherapy With Y90-RadioEmbolization for Metastatic Colorectal Cancer

NCT04108481 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-03-28

No results posted yet for this study

Summary

This clinical trial will be conducted as a single-center, open-label, Phase I/2 trial to evaluate the feasibility and safety of Yttrium-90 radioembolization (Y90-RE) in combination with a fixed dose of of immunotherapy (durvalumab - 750 mg) in subjects with liver-predominant, metastatic colorectal cancer (mCRC), which is mismatch repair proficient/microsatellite stable (pMMR/MSS).

Conditions

Interventions

DRUG

Durvalumab

Immunotherapy

RADIATION

Yttrium-90 RadioEmbolization

Microscopic radioactive particles (TheraSphere®) will be used for radioembolization to deliver the Y90 drug to the liver

Sponsors & Collaborators

  • Biocompatibles UK Ltd

    collaborator INDUSTRY

  • AstraZeneca

    collaborator INDUSTRY

  • University of Iowa

    lead OTHER

Principal Investigators

  • Chandrikha Chandrasekharan, MD · University of Iowa

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-05
Primary Completion
2023-11-17
Completion
2023-11-17
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04108481 on ClinicalTrials.gov