Colorectal Neoplasms
Conditions
Keywords
Liver Metastasis, Colorectal Cancer, Colon Cancer, CRC liver metastasis, patient-derived model
Brief 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.
Interventions
DEVICEMicroOrganoSphere (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.
Sponsors
Xilis, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MOS generation | <14 Days from start of MOS generation | Whether or not MOS could be generated from a biopsy of a patient's colorectal cancer liver metastasis |
Countries
United States
Outcome results
None listed