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 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT06934018
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients, age ≥18 years;
* ECOG Physical condition score :0-1 score;
* Liver biopsy pathologic diagnosis or clinical history combined with laboratory examination and imaging findings can be used to diagnose colorectal cancer in liver;
* The primary lesion of colorectal cancer has been resected or can be resected 4-6 weeks after hepatectomy;
* The number of liver metastases was less than or equal to 5；
* There was no extrahepatic metastases or the metastases were radically resected；
* Preoperative assessment (based on enhanced CT or MRI image AI segmentation combined with three-dimensional reconstruction of hepatic parenchymal blood vessels) enables radical (R0) resection of hepatic oligometastases, and wide surgical margin (the narrowest incisal margin of fresh specimens surgically removed is greater than or equal to 7mm) can be achieved technically, and the incisal margin width is not affected by the intrahepatic vasculature；
* Good liver reserve function (preoperative Child-Pugh grade A liver function, estimated remaining liver volume ≥30%)；
* Preoperative examinations do not show clear surgical contraindications；
* Volunteer to participate in this study and sign the informed consent；
* The compliance was good, and the family members were willing to cooperate with the follow-up；
Exclusion Criteria:
* There are still untreated extra-hepatic metastases；
* Staging hepatectomy is planned, such as PVE combined with hepatectomy, ALPPS, etc；
* The number of liver metastases before chemotherapy was more than 5；
* Complicated with portal vein tumor thrombus or hepatic vein invasion；
* Concurrent with other uncured malignancies or with other primary malignancies for less than 5 years；
* Expected survival time ≤6 months；
* Those who have a history of psychotropic substance abuse and are unable to abstain or have mental disorders；
* Have a history of immunodeficiency or other acquired or congenital immunodeficiency diseases; Or have an autoimmune disease；
* According to the study, there are serious concomitant diseases that endanger the patient's safety or interfere with the patient's completion of the study；
* Patients or family members could not understand the conditions and goals of the study；
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06934018
Study Brief:
Protocol Section:
NCT06934018