None listed
Conditions
Brief summary
This study will assess long term survival after Liver Transplantation for Unresectable ColoRectal Liver Metastases Who is it for? You may be eligible to join this study if you are aged between 18 and 60 years old and have been diagnosed with primary colorectal cancer and liver metastases Study details All participants in this study will receive a liver transplant if no extrahepatic disease and the primary cancer has been removed. Participants will be followed up at 1, 3 and 5 years post-transplantation to determine overall survival, and tumour recurrence. This research will contribute to the field of transplant oncology by better understanding which patient may benefit from a liver transplant.
Interventions
The aim of the study is to see whether selected patients with isolated liver metastases may benefit from liver transplantation.
Liver transplantation is an intervention that participants receive as part of this study.
The liver transplant surgery itself usually takes around 4 to 6 hours, depending on the complexity of the case. During the procedure, the diseased liver is removed, and a healthy donor liver is transplanted. Surgery consist in liver transplantation, removal of the receipient live
The aim of the study is to see whether selected patients with isolated liver metastases may benefit from liver transplantation. Liver transplantation is an intervention that participants receive as part of this study. The liver transplant surgery itself usually takes around 4 to 6 hours, depending on the complexity of the case. During the procedure, the diseased liver is removed, and a healthy donor liver is transplanted. Surgery consist in liver transplantation, removal of the receipient liver containing colorectal liver metastases with a liver from a living donor or deceased donor. After surgery, the patient is transferred to the Intensive Care Unit (ICU) for close monitoring, typically for 1-2 days, to ensure the new liver is functioning well and to manage pain or any complications. The total hospital stay is generally around 7 to 10 days, during which the patient will receive post-operative care, medication to prevent rejection, and guidance on recovery. After discharge, regular follow-up appointments and blood tests are essential to monitor the liver function and overall recovery. Surgery is performed by liver transplant surgeons at RPA hospital. Liver transplant is a standard procedure here in Australia and the rest of world. No specific pre-post sugery requirements.
Sponsors
Sydney Local Health District
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
• Adult from 18 to 60 years old, male of female • Able to consent • Unresectability confirmed by at least 2 Hepatobiliary surgeons based on good quality cross sectional imaging (CT and or MRI). • Time from primary colorectal diagnosis to transplant is >6 months • Primary Colorectal cancer (CRC) tumour stage is <T4a • The patient has undergone appropriate modern systemic chemotherapy +/- monoclonal antibody (eg. FOLFOX +/bevacizumab or FOLFIRI +/- bevacizumab) for >3 months • Demonstrated stability or regression of LM over at minimum the 3 months preceding screening • Not rising CEA in the preceding three months period • Performance status, ECOG 0 • Patients otherwise suitable for liver transplantation.
Exclusion criteria
• Patients with extrahepatic metastases (other than resectable lung metastases or low risk primary cancer). • BRAF mutation • MSI high and/or MMR deficient tumours (should be considered for immunotherapy with checkpoint inhibitors rather than LT). • Significant comorbidities or behaviours that preclude transplantation • There is a tumor progression in the preceding 3 months • Known history of human immunodeficiency virus (HIV) infection • Renal dysfunction with an estimated creatinine clearance of less than 50 ml/min • Unresectaed primary tumour • Tumour thrombus • Patients otherwise not suitable for liver transplantation
Outcome results
None listed