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Metastatic colorectal cancer for Colorectal Cancer (MODEL-CRC Trial)

N/A
Waitlist Available
Led By Michael S Lee, M.D.
Research Sponsored by Xilis, Inc.
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 2 - 3 months post biopsy
Awards & highlights

Summary

The purpose of the study is to determine the feasibility of generating sufficient MicroOrganoSpheres (MOS) from a biopsy of a subject's adenocarcinoma of the colon and/or rectum that is metastatic to the liver and completing a drug screen against patient-derived MOS using standard of care drugs used in the treatment of colorectal cancer (oxaliplatin, irinotecan, 5-FU/capecitabine (Xeloda), bevacizumab, panitumumab or cetuximab, trifluridine/tipiracil (Lonsurf), regorafenib and pembrolizumab or nivolumab) in ≤ 14 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 - 3 months post biopsy
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 - 3 months post biopsy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MOS generation
Secondary outcome measures
Assess the association between standard of care drug sensitivity in MOS to clinical outcome.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Metastatic colorectal cancerExperimental Treatment1 Intervention
Patients having a liver biopsy for suspected adenocarcinoma of the colon and/or rectum that is metastatic to the liver.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MicroOrganoSphere (MOS) drug screen
2022
N/A
~50

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Who is running the clinical trial?

Xilis, Inc.Lead Sponsor
Kristen LechleiterStudy DirectorXilis, Inc.
Study OfficialStudy DirectorXilis, Inc.
14 Previous Clinical Trials
3,618 Total Patients Enrolled
~16 spots leftby Sep 2025
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