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New treatment option for Colorectal Cancer
Official title Liver Transplantation for Non-resectable Colorectal Liver Metastases: Translational Research
ClinicalTrials.gov ID: NCT05398380
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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.
You likely can't join if
- . Exclusion Criteria:
- 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.
See the full eligibility criteria
- 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...
- 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...
- . Exclusion Criteria:
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Barcelona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.