Status:
NOT_YET_RECRUITING
SALT for Unresectable Colorectal Liver Metastases
Lead Sponsor:
RenJi Hospital
Conditions:
Colon Cancer Liver Metastases
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Colon cancer is a common malignancy with a low survival rate worldwide, and unresectable colon cancer liver metastases (ICRLM) have a worse prognosis. The liver is the most common metastatic organ of ...
Detailed Description
Colorectal cancer is currently the third most common malignant tumor in the world, and about 20%-50% of patients have liver metastases at the time of diagnosis or progress to liver metastases thereaft...
Eligibility Criteria
Inclusion
- Age 18-75;
- Physical fitness status (ECOG) 0\~1;
- 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
- Liver metastases (CRLM) located in bilateral livers, or limited to liver and unresectable CRLM after discussion by MDT;
- According to PET/CT, CT and MRI, there are no other abdominal metastases except the liver or 1-3 resectable lung metastases;
- 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);
- The CEA (carcinoembryonic antigen) value before screening is ≤80 µg/L or the highest level after treatment is reduced by ≥ 50%;
- Sign the informed consent form.
Exclusion
- Extrahepatic tumor burden (except for resectable lung metastases) and/or large vessel tumor infiltration;
- The largest liver tumor lesion \>5.5cm at the time of screening;
- Tumor progression during chemotherapy or severe comorbidities that make transplantation impossible;
- BRAF mutation and/or microsatellite instability primary tumor (MSI);
- Suffering from other primary malignant tumors in the past 5 years;
- Cardiopulmonary disease that cannot be corrected, with high surgical risk, or anatomical abnormality that makes liver transplantation impossible;
- Substance abuse, medical, psychological or social conditions may interfere with the patient's participation in the study or evaluation of the study results;
- Combined with AIDS and other diseases that affect surgery or tumor progression;
- Pregnant or lactating patients;
- Other reasons that the researchers think are not suitable for participation.
Key Trial Info
Start Date :
October 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06069960
Start Date
October 20 2023
End Date
June 30 2027
Last Update
October 6 2023
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