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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05189171
Other study ID # 146057.60
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 25, 2022
Est. completion date December 2025

Study information

Verified date January 2024
Source Xilis, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 46
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria: - Subject signed a valid, Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent form. - Male or female age 18 or older when written informed consent is obtained. - Study candidate is willing and able to comply with all protocol-required procedures and assessments. - Study candidate either 1. is scheduled for or plans to be scheduled for a biopsy of the liver OR 2. has a previous histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon and/or rectum that is metastatic to the liver. Key Exclusion Criteria: - If already scheduled for a biopsy of the liver: liver biopsy was ordered to help diagnose, determine the severity of, or treat a disease that is unrelated to colorectal cancer (e.g., nonalcoholic fatty liver disease, chronic hepatitis B or C, autoimmune hepatitis, alcoholic liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, hemochromatosis, Wilson's disease, etc.). - Study candidate is participating (or intends to participate) in another clinical study AND either: 1. is currently receiving investigational systemic therapy for adenocarcinoma of the colon and/or rectum that is metastatic to the liver as part of that study OR 2. that study only allows investigational systemic therapy for adenocarcinoma of the colon and/or rectum that is metastatic to the liver (simultaneous participation in a clinical trial standard of care control arm is allowed, provided the subject is either already randomized or may be randomized to the control arm). - Confirmed histological or cytological diagnosis of neuroendocrine colorectal cancer.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
MicroOrganoSphere (MOS) drug screen
Patient-derived models of cancer, called MOS, will be generated from a biopsy of a subject's adenocarcinoma of the colon and/or rectum that is metastatic to the liver and a drug screen using standard-of-care drugs used will be completed (oxaliplatin, irinotecan, 5-FU/capecitabine (Xeloda), bevacizumab, panitumumab or cetuximab, trifluridine/tipiracil (Lonsurf), regorafenib and pembrolizumab or nivolumab). Subjects will receive standard-of-care therapy for CRC dictated by their treating physicians.

Locations

Country Name City State
United States The University of Texas MD Anderson Cancer Center Houston Texas
United States Mayo Clinic Jacksonville Florida
United States The University of Tennessee Medical Center Knoxville Tennessee
United States Mayo Clinic Rochester Minnesota
United States Mayo Clinic Scottsdale Arizona
United States Inland Imaging Spokane Washington
United States MedStar Washington Hospital Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Xilis, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (32)

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* Note: There are 32 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary MOS generation Whether or not MOS could be generated from a biopsy of a patient's colorectal cancer liver metastasis <14 Days from start of MOS generation
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