Actively Recruiting
Liver Transplantation for Non-Resectable Colorectal Liver Metastasis
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2022-01-11
20
Participants Needed
1
Research Sites
469 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study aims to evaluate the efficacy of liver transplantation in the context of non-resectable colorectal liver metastasis. The primary endpoint is the overall survival in this group of patients while the secondary endpoint is the disease-free survival. Patients included in this protocol will be evaluated either for whole or partial liver transplantation from deceased or living donors. Type of different transplantations proposed are as follows: 1. Whole liver graft or partial liver (split) from a deceased donor 2. Partial liver graft retrieved from a deceased donor and orthotopically implanted after having performed a left hepatectomy in the recipient. 3. Partial liver graft retrieved from a deceased donor and heterotopically implanted if total hepatectomy can not be performed. 4. Partial liver graft retrieved from a living donor and orthotopically implanted after having performed total hepatectomy. 5. Partial liver graft retrieved from a living donor and orthotopically implanted after having after having performed a left hepatectomy in the recipient. 6. Partial liver graft retrieved from a living donor and heterotopically implanted if total hepatectomy can not be performed. In cases 2-3-5-6 total hepatectomy of native liver can be secondarily performed after having achieved a proper graft hypertrophy in order to avoid a small for size syndrome
CONDITIONS
Official Title
Liver Transplantation for Non-Resectable Colorectal Liver Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary tumor surgically removed following standard cancer treatment with no residual tumor (R0 resection)
- Colorectal liver metastasis deemed non-resectable either initially or after previous liver surgery
- No local recurrence of primary colon cancer confirmed by PET scan, CT scan, and colonoscopy
- No cancer spread outside the liver confirmed by PET scan and CT scan
- Good performance status (ECOG 0 or 1)
- Neutrophil count greater than 1,000
- Received at least one chemotherapy regimen for at least 3 months with partial response or stable disease by modified RECIST criteria
- Carcino-Embryonic Antigen (CEA) less than 80 µg/L or reduced by at least 50% from highest observed level
- Provided written informed consent
- No other contraindications to liver transplantation
You will not qualify if you...
- Presence of other cancers
- Local recurrence of the primary tumor
- Cancer spread outside the liver
- Patients who have not received any neoadjuvant or adjuvant therapy
- Palliative surgery of the primary tumor
- Any other reason judged by investigators to contraindicate participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, Italy, 40138
Actively Recruiting
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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