SALT for Unresectable Colorectal Liver Metastases

NCT06069960 | Not Yet Recruiting

• 1 other identifier: LY2023-186-C
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Colon Cancer Liver Metastases

Keywords

liver transplantation; two-stage liver resection; colorectal liver metastases

Outcome Measures

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.

  3 years after the second liver resection

Secondary Outcomes (1)

• Disease-free survival，DFS

  1 month, 3 months, 6 months, 1 year, 2 years and 3 years post-transplant

Study Arms (1)

Surgical group

EXPERIMENTAL

SALT operation plan for patients who meet the enrollment conditions and successfully match the donor liver: Hemihepatectomy 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.

Procedure: sequential adult left lateral lobe liver transplantation (SALT)

Interventions

sequential adult left lateral lobe liver transplantation (SALT) PROCEDURE

Hemihepatectomy 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.

Surgical group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: SALT operation plan for patients who meet the enrollment conditions and successfully match the donor liver: Hemihepatectomy 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.

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: October 6, 2023
• Study Start: October 20, 2023
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share