Status:
RECRUITING
Liver Transplantation for Non-resectable Colorectal Liver Metastases: Translational Research
Lead Sponsor:
Hospital Vall d'Hebron
Conditions:
Colorectal Cancer
Liver Metastases
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The patients with non-resectable colorectal liver metastases (CRLM) have always being considered a particular subgroup of CRLM in which the therapeutic approach, is focused on strategies that allow a ...
Detailed Description
A prospective multicenter Spanish clinical phase II trial is proposed. The study population will consist of male and female with non-resectable CRLM, who are 18 to 70 years old, inclusive, at the time...
Eligibility Criteria
Inclusion
- Willing and able to provide written informed consent.
- Male or female, aged 18-70 years old inclusive at study entry.
- ECOG (Eastern Cooperative Oncology Group) 0 or 1.
- Histologically-proven primary colorectal tumor.
- Bilateral, limited at liver and non-resectable CRLM by consensus in Multidisciplinary Committee.
- Resection of primary colorectal tumor according oncological principles and adequate TNM stage.
- Time from primary colorectal tumor resection to transplant ≥ 12 months.
- Primary colorectal tumor stage ≤ T3N1. If time between primary tumor resection is ≥ 2 years, stage T4N0 or T4N2 is accepted.
- No signs of extrahepatic metastatic disease according to PET/CT scan, CT and pelvic MRI.
- The patient has undergone systemic chemotherapy for a minimum of 3 months at the time of screening and maximum of 2 lines of fluoropyrimidine based chemotherapy combined or not with irinotecan or oxaliplatin associated or no not with targeted therapy based in molecular biomarkers.
- Demonstrated stability or partial regression of CRLM following RECIST criteria v 1.1., at minimum 3 months since the last treatment received and immediately prior to screening.
- CEA (Carcinoembryonic antigen) values ≤ 80 µg/L immediately prior to screening.
- Adequate blood test regarding:
- Creatinine ≤1.25 x upper normal level or estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73m2 using following the Chronic Kidney disease epidemiology collaboration (CKD-EPI) formula.
- Platelets ≥80 × 109/L
- Neutrophiles ≥ 2.5 × 109/L
- Patients with hepatic failure after resection will be considered if it occurs as a consequence of an inadequate preoperative estimation of the functional volume that would have contraindicated the surgery. They should meet the inclusion criteria and none of the exclusion criteria.
Exclusion
- Largest Lesion \>5.5cm immediately prior to screening
- Patients with Lynch Syndrome
- BRAF mutation and/or primary tumor of microsatellite instability (MSI)
- Recurrence of primary tumor confirmed by colonoscopy or pelvic MRI within the last 12 months prior to screening.
- Previous or concurrent cancer in the last 5 years. Any cancer curatively treated 5 years prior to entry or treated basal cell carcinoma is permitted.
- Substance abuse, medical, psychological or social conditions that may interfere with the patient´s participation in the study or evaluation of the study results.
- Cardiac or pulmonary disease uncontrolled as contraindication for any surgical procedure.
- Active infection.
- Pregnant or breast-feeding patients
- Any reason why in the opinion of the investigator, the patient should not participate.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT05398380
Start Date
January 1 2022
End Date
December 31 2026
Last Update
October 2 2024
Active Locations (1)
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1
Department of HPB Surgery and Transplants, Hospital Vall d´Hebron
Barcelona, Spain, 08035