Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT04511793
Eligibility Criteria:
Inclusion Criteria:
* Patients age 18-80
* Eastern Cooperative Oncology Group score 0-1
* Fit for major surgery
* Without evidence of cirrhosis or portal hypertension
* Labs within 14 days of surgery: White blood cells ≥3 k/uL, Absolute Neutrophil Count ≥ 1.5 k/uL, Platelets ≥ 100K /uL, Creatinine ≤ 1.5 mg/dL, Total bilirubin ≤1.5 mg/dL
* Disease should be liver-only or liver-dominant
* Arterial anatomy must be suitable, determined by the surgeon
* Primary tumor may be in place in the case of colorectal liver metastases. Patients may have colorectal liver metastases (unresectable, borderline resectable, resectable), or unresectable intrahepatic cholangiocarcinoma.
* Chemotherapy completed at least 3 weeks prior to surgery.
Exclusion Criteria:
* Patients younger than 18 or older than 80 years
* Eastern Cooperative Oncology Group score 2+
* Unfit for major surgery
* Inherent liver disease with evidence of cirrhosis or portal hypertension
* Widely metastatic disease is absolutely contraindicated
* Pregnant women (Women of childbearing potential who have not completed menopause, had a hysterectomy and/or both tubes and/or both ovaries removed and have a partner who is able to father children will have a blood or urine pregnancy test performed, and it must be negative in order to continue in the study.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04511793
Study Brief:
Protocol Section:
NCT04511793