LY2023-186-C

About this trial

Last updated 2 years ago

Study ID

LY2023-186-C

Status

Not yet recruiting

Type

Interventional

Phase

N/A

Placebo

Accepting

18 to 75 Years

All

Not accepting

Healthy Volunteers

Trial Timing

Started 2 years ago

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.

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.

SALT for Unresectable Colorectal Liver Metastases