SALT for Unresectable Colorectal Liver Metastases
ConditionColon Cancer Liver Metastases
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRenJi Hospital
About this trial
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 colorectal cancer, and palliative chemotherapy is the only option for most ICRLM patients. Regrettably, the median survival time of all patients receiving chemotherapy is only 2 years, and the 5-year survival rate is only 10%. Liver transplantation is an ideal choice for patients with ICRLM, which can significantly improve the postoperative survival rate. But the most serious problem facing such patients is the shortage of donor livers. In 2015, Norwegian scholars proposed a new surgical method, that is, resection and partial liver segment (2-3 segment) transplantation combined with delayed total hepatectomy can greatly alleviate the shortage of liver donors in the above-mentioned patients. Based on the experience of clinical operation, our center proposes and designs a clinical study of sequential adult left lateral lobe liver transplantation (SALT) for the treatment of iCRLM. On the basis of RAPID, the safety and efficacy of sequential adult left lateral lobe liver transplantation were evaluated for the above patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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);
Trial design
Design model
Single group
Treatments tested in this trial
sequential adult left lateral lobe liver transplantation (SALT)
Procedure/SurgeryHemihepatectomy combined with left lateral lobe liver transplantation was performed first, and residual liver resection was performed after the graft grew to a sufficient functional liver volume.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Surgical groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall survival（OS）
To describe overall survival in patients with unresectable colorectal cancer liver metastases treated with sequential adult left lateral lobe liver transplantation.
Time frame
3 years after the second liver resectionSecondary outcomes
1
Disease-free survival，DFS
Describe the tumor-free survival period of SALT in the treatment of iCRLM
Time frame
1 month, 3 months, 6 months, 1 year, 2 years and 3 years post-transplantLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: