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 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT05861505
Eligibility Criteria:
Inclusion criteria
* Age \>18 years
* Good performance status (ECOG 0-2 // ASA 1-3)
* Histological documentation of primary colorectal tumor
* Local treatment performed for initial CRLM
* New recurrence ≤12 months
* ≥1 locally treatable CRLM (resectable\* and/or ablatable)
* Total number of new CRLM ≤5
* Chemo-naïve or history of response to CAPOX/FOLFOX/FOLRIRI
* Life expectancy of at least 12 weeks
* Adequate bone marrow, liver and renal function
* Written informed consent Exclusion criteria
* Extrahepatic disease
* MSI/dMMR
* Radical local treatment unfeasible or unsafe (e.g. insufficient future liver volume)
* Compromised liver function (e.g. signs of portal hypertension, INR \> 1,5 without use of anticoagulants, ascites)
* Uncontrolled infections (\> grade 2 NCI-CTC version 3.0)
* Pregnant or breast-feeding subjects
* Immuno- or chemotherapy ≤ 6 weeks prior to the randomization
* Severe allergy to contrast media not controlled with premedication
* Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
ECOG = Eastern Cooperative Oncology Group, ASA = American Society of Anesthesiologists, MSI = Microsatellite instability, dMMR = deficient mismatch repair
\* Resection for resectable lesions considered possible obtaining negative resection margins (R0) and preserving adequate liver reserve
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05861505
Study Brief:
Protocol Section:
NCT05861505