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:
2025-12-24 @ 12:13 PM
Ignite Modification Date:
2025-12-24 @ 12:13 PM
NCT ID:
NCT03125161
Eligibility Criteria:
Inclusion Criteria:
* All patients must meet the following criteria:
* Patients must have histologically confirmed incurable CRLM and no clinical or radiographic evidence of extrahepatic disease
* Patients is medically eligible to receive HAI, as determined by the MDT (multidisciplinary team)
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
* Age \> 18 years
* Subject life expectancy \> 3 months
* Platelets \> 100×103/mm3
* Total bilirubin \<1.5mg/dl
* Creatinine level \< 2.0 mg/dl
* All patients must sign an informed consent form
Exclusion Criteria:
* The CRLM is amenable to curative surgical therapy
* Prior radiation, TACE or HAI to the liver
* Uncorrectable coagulopathy
* Subject is pregnant, nursing, or wishes to become pregnant during the study Other serious medical condition (uncontrolled infection, uncontrolled cardiac disease) would preclude study treatment or impact survival
* Current or planned treatment with any experimental chemotherapy or target drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03125161
Study Brief:
Protocol Section:
NCT03125161