Actively Recruiting
Liver Transplantation for Non-resectable Colorectal Liver Metastases: Translational Research
Led by Hospital Vall d'Hebron · Updated on 2024-10-02
35
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 potential surgery like neoadjuvant systemic treatments. But, the underlying biology that causes this particular profile of spread in a proportion of patients that always recur and progress in the liver has not been properly characterized from a biological point of view. Unfortunately, these patients finally develop liver metastasis not amenable for local treatments and become refractory to systemic treatments even without developing extrahepatic liver metastases. As a result, liver transplantation (LT) is a potential for patients without extrahepatic involvement and nonresectable CRLM. There are several studies that aims to evaluate if LT increases overall survival compared to best alternative care. To our knowledge, none of these studies incorporate objectives focused on the underlying tumor biology of this particular population and the development of focused strategies including a dynamic disease monitoring and targeted treatments for this particular population.The METLIVER trial will permit to expand the genetic studies to the whole complexity of metastatic lesions and a more precise evaluation of their genetic heterogeneity. Moreover, it will help to precise the type of genetic analyses on liquid biopsies that can be designed for patients that will unfortunately relapse mostly with lung metastases after LT. Our proposal will maximize the opportunity to produce an unprecedented knowledge on CRLM evolution and will provide new opportunities for relapsed patients.
CONDITIONS
Official Title
Liver Transplantation for Non-resectable Colorectal Liver Metastases: Translational Research
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent
- Male or female, aged 18-70 years old inclusive at study entry
- ECOG performance status 0 or 1
- Histologically confirmed primary colorectal tumor
- Bilateral, limited to liver and non-resectable colorectal liver metastases by multidisciplinary consensus
- Primary colorectal tumor resected following oncological principles with adequate TNM stage
- At least 12 months elapsed from primary colorectal tumor resection to transplant
- Primary tumor stage T3N1 or less; if time since primary resection is 2 years or more, stage T4N0 or T4N2 accepted
- No signs of extrahepatic metastatic disease on PET/CT, CT, and pelvic MRI
- Received systemic chemotherapy for minimum 3 months and maximum 2 lines of fluoropyrimidine-based chemotherapy with or without irinotecan or oxaliplatin, with or without targeted therapy
- Demonstrated stability or partial regression of liver metastases by RECIST criteria v1.1 for at least 3 months prior to screening
- Carcinoembryonic antigen (CEA) values ≤ 80 µg/L immediately prior to screening
- Adequate blood tests with creatinine ≤1.25 x upper normal limit or eGFR ≥60 mL/min/1.73m2, platelets ≥80 x 10⁹/L, neutrophils ≥2.5 x 10⁹/L
- Patients with hepatic failure after resection may be included if meeting criteria and no exclusion criteria
You will not qualify if you...
- Largest liver lesion greater than 5.5 cm immediately prior to screening
- Diagnosis of Lynch Syndrome
- Presence of BRAF mutation or primary tumor with microsatellite instability (MSI)
- Recurrence of primary tumor confirmed by colonoscopy or pelvic MRI within 12 months prior to screening
- Previous or concurrent cancer within last 5 years, except treated basal cell carcinoma or cancer treated curatively more than 5 years ago
- Substance abuse or medical, psychological, or social conditions interfering with study participation or evaluation
- Uncontrolled cardiac or pulmonary disease contraindicating surgery
- Active infection
- Pregnant or breastfeeding patients
- Any other reason the investigator deems the patient unsuitable for participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of HPB Surgery and Transplants, Hospital Vall d´Hebron
Barcelona, Spain, 08035
Actively Recruiting
Research Team
C
CRISTINA DOPAZO, MD/PhD
CONTACT
C
CRISTINA DOPAZO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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