Liver transplantation for patients with non-resectable colorectal liver metastases
Clinical Impact of Molecular Biomarkers in Liver Transplantation for Non-resectable Colorectal Liver Metastases: Translational Research
This study is testing whether liver transplantation can help patients with colorectal cancer that has spread to the liver when surgery isn't an option.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Hospital Vall d'Hebron Academic / other |
| Drugs / interventions | chemotherapy, bevacizumab |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT05398380 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the potential of liver transplantation as a treatment for patients with non-resectable colorectal liver metastases (CRLM). It involves a multicenter approach where eligible patients will receive chemotherapy and be evaluated for liver transplantation based on specific criteria. The study aims to analyze the biological characteristics of the tumors removed during transplantation to better understand the underlying mechanisms of this condition. Participants will be monitored for safety, survival, and disease recurrence over a five-year period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with histologically-proven colorectal cancer and non-resectable liver metastases without extrahepatic disease.
Not a fit: Patients with extrahepatic metastatic disease or those who do not meet the specific inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for patients with non-resectable colorectal liver metastases.
How similar studies have performed: While there have been studies evaluating liver transplantation for similar conditions, this trial incorporates a unique focus on the biological analysis of tumors, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Willing and able to provide written informed consent.
2. Male or female, aged 18-70 years old inclusive at study entry.
3. ECOG (Eastern Cooperative Oncology Group) 0 or 1.
4. Histologically-proven primary colorectal tumor.
5. Bilateral, limited at liver and non-resectable CRLM by consensus in Multidisciplinary Committee.
6. Resection of primary colorectal tumor according oncological principles and adequate TNM stage.
7. Time from primary colorectal tumor resection to transplant ≥ 12 months.
8. Primary colorectal tumor stage ≤ T3N1. If time between primary tumor resection is ≥ 2 years, stage T4N0 or T4N2 is accepted.
9. No signs of extrahepatic metastatic disease according to PET/CT scan, CT and pelvic MRI.
10. 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.
11. 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.
12. CEA (Carcinoembryonic antigen) values ≤ 80 µg/L immediately prior to screening.
13. 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
14. 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 Criteria:
1. Largest Lesion \>5.5cm immediately prior to screening
2. Patients with Lynch Syndrome
3. BRAF mutation and/or primary tumor of microsatellite instability (MSI)
4. Recurrence of primary tumor confirmed by colonoscopy or pelvic MRI within the last 12 months prior to screening.
5. 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.
6. Substance abuse, medical, psychological or social conditions that may interfere with the patient´s participation in the study or evaluation of the study results.
7. Cardiac or pulmonary disease uncontrolled as contraindication for any surgical procedure.
8. Active infection.
9. Pregnant or breast-feeding patients
10. Any reason why in the opinion of the investigator, the patient should not participate.
Where this trial is running
Barcelona
- Department of HPB Surgery and Transplants, Hospital Vall d´Hebron — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Ramón Charco — Department of HPB Surgery and Transplants, Hospital Universitario Vall d´Hebron
- Study coordinator: CRISTINA DOPAZO, MD/PhD
- Email: cristina.dopazo@vallhebron.cat
- Phone: +34932746113
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.