Partial liver Segment 2/3 Transplantation with delayed total hepatectomy as treatment for selected Patients with Liver Metastases from Colorectal Carcinoma

Not Applicable

• Conditions: C18; C78.7; Secondary malignant neoplasm of liver and intrahepatic bile duct; Malignant neoplasm of colon

• Registration Number: DRKS00017730
• Lead Sponsor: Klinik für Allgemein-, Viszeral-, und Transplantationschirurgie, Klinikum der Universität München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to GCP, and national/local regulations.
2. Primary Colorectal cancer tumor stage is =T4a
3. Primary tumor removed with adequate (R0) resection margins, including circumferential resection margins (CRM) of at least =2mm for rectal cancer patients.
4. Time from primary CRC resection to transplant is =6 months
5. Bilateral and non-resectable LM
6. No major vascular invasion by LM; metastases isolated to liver
7. The patient has undergone first-line systemic chemotherapy (doublet/triplet +/- bevacizumab or doublet/triplet +/- anti-EGFR moAb) for =8 weeks
8. Demonstrated stability or regression of LM, according to RECIST-criteria, over at minimum the 3 months preceding the screening
9. Carcinoembryonic Antigen (CEA) values are stable or decreasing at all time points before the transplant surgery.
10. No signs of extrahepatic metastatic disease or local recurrence according to PET/CT scan within 12 weeks before deceased donor partial liver transplantation, and 4 weeks before living donation
11. No signs of extrahepatic metastatic disease on CT thorax/abdomen/pelvis within 12 weeks before deceased donor partial liver transplantation, and 4 weeks prior to living donation.
12. No local recurrence according to MR-pelvis scan in patients with rectal cancer within 12 weeks before deceased donor partial liver transplantation, and 4 weeks before living donation
13. No signs of local recurrence judged by colonoscopy within 12 months prior transplantation
14. Good performance status, ECOG 0 or 1.
15. Satisfactory blood tests Hb >10g/dl, neutrophiles >1.0 (after any G-CSF), TRC >75, Bilirubin<2 x upper normal level, ASAT,ALAT<5 x upper normal level, Creatinine <1.25 x upper normal level. Albumin above the lower normal level. Thrombocyte count > 100

Exclusion Criteria

1. Previous or concurrent cancer (with some exceptions)
2. Prior liver resection (performed with curative intent) where current LM represents recurrent disease
3. Extrahepatic/metastatic disease
4. BRAF-V600 mutation as a predictor of very poor prognosis
5. Microsatellite instability (MSI) or mismatch repair deficiency (MMRd) that can be treated by check-point inhibition
6. CEA > 80 ng/ml at baseline
7. Any confirmed rise of CEA during chemotherapy
8. Weight loss >10% during the last three months
9. Any condition that is unstable or which could jeopardize the safety of the patient

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Safety (Clavien-Dindo classification) [Time Frame: 6 months after transplantation]<br>2. Percent of patients completing the hepatectomy within 30 days after accessory partial (S2+3) liver transplantation and left hemihepatectomy (S1-3 +/- 4) [Time Frame: 30 days after transplantation]<br>

Secondary Outcome Measures

Name	Time	Method
1. Patient Survival [Time Frame: 14, 30, 90 days, and 6, 12, 60 months after transplantation]<br>2. Recurrence-free survival [Time Frame: up to 60 months after transplantation]<br>3. Patterns of cancer recurrence after liver transplantation [Time Frame: up to 60 months after transplantation]<br>4. Survival of study patients compared to standard therapy in a real world population matched for inclusion and exclusion criteria<br>5. Self-reported quality of life as assed by EORTC QLQ-C30<br>6. Determination of volume and function of transplanted partial donor graft over time<br>7. Tumor proliferative activity at first and second resection (KI-67 proliferation Index)<br>8. Evaluation of cell-free tumor DNA (ctDNA) 4-10 weeks after LTX by liquid biopsy <br><br>