Ensayos clínicos

Inclusion Criteria:

Subjects may participate in this study if all of the following criteria apply:

• Provide written informed consent.
• Male or female ages 18 or older.
• Evidence of cancer of the colon or rectum that is metastatic to the liver.
  • NOTE:  patients may enroll prior to receiving clinical biopsy results. If they are not confirmed to have adenocarcinoma of the colon or rectum that is metastatic to the liver, they will not be evaluable.
• Treating physician planning to treat CRC liver metastasis with a standard of care therapy.
• Previous adjuvant or neoadjuvant therapies allowed.
• Biopsy may be obtained prior to starting the 2nd cycle of a new standard of care therapy.
• Measurable disease as measured by RECIST 1.1 criteria.
• Life expectancy of ≥ 12 weeks.
• ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2. 
• Adequate coagulation function as evidenced by:
  • Absolute neutrophil count ≥ 1.0 x 10^9/L;
  • Platelets ≥ 50 x 10^9/L;
  • Hemoglobin ≥ 8 g/dL (transfusions are permitted to achieve baseline hemoglobin level);
• ALT/AST (alanine aminotransferase (ALT) / aspartate aminotransferase (AST)) < 2.5 x upper limit of normal (ULN); or
• < 5 x ULN in the presence of liver metastases;
• Total bilirubin < 1.5 x ULN (if total bilirubin ≥ 1.5 x ULN then the subject may participate if the direct bilirubin is ≤ 1.5 x ULN);
• Creatinine clearance > 30 mL/min measured or calculated by Cockcroft-Gault equation or the estimated glomerular filtration rate (GFR) > 30 mL/min/1.73 m^2 using the MDRD;
• INR < 1.5.

Exclusion Criteria:

Subjects may not participate if any of the following criteria apply:

• Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment.
• Clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from day 1 of start of therapy, New York Heart Association Class II, III or IV congestive heart failure, and arrhythmia requiring therapy.
• Presence of significant concurrent, uncontrolled medical condition including but not limited to renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, active infection, non-healing wound, or psychiatric disease that excludes them from receiving chemotherapy.
• Pregnant or actively breastfeeding women (Pregnant or breastfeeding women are not candidates for chemotherapy).

Eligibility last updated 7/20/22. Questions regarding updates should be directed to the study team contact.