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 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT05428735
Eligibility Criteria:
Inclusion Criteria:
* Patients with primarily unresectable/ potentially resectable CRLM with a FLR \<30% (\<40% in chemotherapy damaged livers)
* Patients with non-resected primary CRC may be included if there is an intention to resect the CRC after the liver treatment (liver first approach) or simultaneously during one of the liver procedures.
* Patients with resectable or ablatable lung or brain metastases can be included (statement about the resectability of these extrahepatic metastases by a tumor board needs to be available)
* 18 Years and older
* Men and women
* Able to understand the trial and provide informed consent.
Exclusion Criteria:
* Pregnant or lactating female.
* Premenopausal females not able or willing to commit to oral contraception
* Patients with prohibitive comorbidities, decision made by local team
* Any patient with non-resectable or non-ablatable extrahepatic disease
* Patients with hepatic malignancies other than CRLM
* Progression of disease by RECIST criteria after cytoreduction chemotherapy
* Complete response after conversion chemotherapy
* Staging CT and (if indicated) CT/MRI brain that demonstrates non-resectable extrahepatic disease
* The anatomy of the liver or manifestation of tumors in relation to the liver veins prohibits the use of combined PVE/HVE.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05428735
Study Brief:
Protocol Section:
NCT05428735