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 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT06069960
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-75;
2. Physical fitness status (ECOG) 0\~1;
3. Histologically confirmed primary colorectal neoplasm. The time from primary colorectal tumor resection to transplantation is ≥3 months and the stage of primary colorectal tumor is ≤T3N1. Accept T4N0 or T4N2 if primary tumor resection interval is ≥ 2 years
4. Liver metastases (CRLM) located in bilateral livers, or limited to liver and unresectable CRLM after discussion by MDT;
5. According to PET/CT, CT and MRI, there are no other abdominal metastases except the liver or 1-3 resectable lung metastases;
6. Patients have received at least 6-8 weeks of first-line chemotherapy at the time of screening. According to RECIST criteria, CRLM was stable or partially regressed during and after treatment (still not completely resectable);
7. The CEA (carcinoembryonic antigen) value before screening is ≤80 µg/L or the highest level after treatment is reduced by ≥ 50%;
8. Sign the informed consent form.
Exclusion Criteria:
1. Extrahepatic tumor burden (except for resectable lung metastases) and/or large vessel tumor infiltration;
2. The largest liver tumor lesion \>5.5cm at the time of screening;
3. Tumor progression during chemotherapy or severe comorbidities that make transplantation impossible;
4. BRAF mutation and/or microsatellite instability primary tumor (MSI);
5. Suffering from other primary malignant tumors in the past 5 years;
6. Cardiopulmonary disease that cannot be corrected, with high surgical risk, or anatomical abnormality that makes liver transplantation impossible;
7. Substance abuse, medical, psychological or social conditions may interfere with the patient's participation in the study or evaluation of the study results;
8. Combined with AIDS and other diseases that affect surgery or tumor progression;
9. Pregnant or lactating patients;
10. Other reasons that the researchers think are not suitable for participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06069960
Study Brief:
Protocol Section:
NCT06069960