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Clinical Trial Summary

The primary objective of this study is to determine the feasibility of generating sufficient MicroOrganpSphere (MOS) from a biopsy of a patient's colorectal cancer liver metastasis to determine sensitivity to standard of care drug used in the treatment of colorectal cancer (oxaliplatin, irinotecan, 5-FU/Xeloda, Bevacizumab, Panitumumab or Cetuximab, Lonsurf, Regorafenib and Pembrolizumab or Nivolumab) in < 14 days. The secondary objective of this study is to assess the association between standard of care drug sensitivity in MOS to clinical outcome of patient treated with standard of care therapy from which the MOS was derived.


Clinical Trial Description

The purpose of this study is to assess the feasibility of creating patient derived models of cancer (i.e., MOS) from patients with colorectal cancer liver metastasis. In this study, we have focused on a precision medicine strategy for patients with CRC liver metastasis. Figure 2 shows the schema for this study. Participating subjects will undergo biopsy of their liver lesion and the diagnosis of CRC liver metastasis will be verified by pathology. Patients will be treated with standard of care therapy determined by their treating physician. As part of standard of care therapy, patients will undergo lab work including CEA (carcinoembryonic antigen) and CT of the chest, abdomen and pelvis for staging and measurement of tumor size every two months. Up to 250 patients will be enrolled to the study. Enrolled subjects are defined as subjects who give informed consent. Screen failures are defined as subjects who give informed consent and do not meet eligibility criteria. Accrued subjects are defined as subjects who give informed consent and meet eligibility criteria. Evaluable subjects are defined as those who accrue, receive the study biopsy and have cytologically or histologically confirmed adenocarcinoma of the colon or rectum that is metastatic to the liver. If the biopsy tissue is not confirmed to be adenocarcinoma of the colon or rectum, the subject will be considered non-evaluable and will be replaced. MOS will be generated from the study biopsy and a drug screen will be performed to determine sensitivity to standard of care therapy. In our experience, this method has been proved to have a 75% success rate of generating MOS and testing sensitivity to standard of care therapy from tumor biopsy samples. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05189171
Study type Observational
Source Xilis, Inc.
Contact David Hsu, MD
Phone +1 (984) 377-6738
Email [email protected]
Status Not yet recruiting
Phase
Start date January 31, 2022
Completion date December 30, 2023

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