Comparing liver transplantation to chemotherapy for colorectal cancer patients with liver metastases
A Randomized Clinical Trial Comparing Overall Survival in Selected Patients With ColoRectal Carcinoma Treated by Liver Transplantation or Chemotherapy
This study is testing whether liver transplantation works better than chemotherapy for colorectal cancer patients whose liver cancer can't be surgically removed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Drugs / interventions | chemotherapy, bevazicumab |
| Locations | 1 site (Oslo) |
| Trial ID | NCT03494946 on ClinicalTrials.gov |
What this trial studies
This trial is a randomized control trial that evaluates the effectiveness of liver transplantation (Ltx) versus chemotherapy and other treatment options in patients with non-resectable colorectal cancer liver metastases. Patients will be randomly assigned to either the Ltx group or the chemotherapy group, with the latter potentially receiving treatments such as TACE or SIRT. The study aims to include patients who have shown progressive disease on first-line chemotherapy or have stopped treatment due to toxicity. Those in the Ltx group will be monitored for eligibility and may be removed from the waiting list if they do not receive a donor liver graft within three months.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically verified adenocarcinoma of the colon or rectum, who have liver metastases not amenable to resection and no signs of extrahepatic metastatic disease.
Not a fit: Patients with extensive extrahepatic metastatic disease or those who do not meet the eligibility criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that may improve survival rates for patients with advanced colorectal cancer and liver metastases.
How similar studies have performed: While liver transplantation for colorectal cancer is a novel approach, similar studies have shown promising results in specific patient populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically verified adenocarcinoma in colon/rectum. * Liver metastases, not amenable to liver resection * No signs of extra hepatic metastatic disease or local recurrence according to PET/CT scan within 6 weeks prior to the faculty meeting at the transplant unit, except patients may have resectable lung lesions all \< 15mm. * No signs of extra hepatic metastatic disease on CT or MRI thorax/abdomen/pelvis within 6 weeks prior to the faculty meeting at the transplant unit, except resectable lung lesions all \< 15mm. * No signs of extra hepatic metastatic disease on PET/CT within 6 weeks prior to the faculty meeting at the transplant unit, except patients may have resectable lung lesions all \< 15mm * Good performance status, ECOG 0 or 1. * Satisfactory blood tests Hb \>10g/dl, neutrophiles \>1.0 (after any G-CSF), TRC \>75, Bilirubin\<1.5 x upper normal level, ASAT, ALAT\<5 x upper normal level, Creatinine \<1.25 x upper normal level. Albumin above lower normal level. * Signed informed consent and expected cooperation of the patients for the treatment and followup must be obtained and documented according to GCP, and national/local regulations. * All patients should have progressive disease according to RECIST-criteria, or intolerance to 1. line chemotherapy. Patients must be randomized before evaluation 8-12 weeks after starting 2. line chemotherapy. Exclusion Criteria: * Weight loss \>10% the last 6 months * Patient BMI \> 30 * Previous resection of local relapse or non-hepatic metastasis within the last 2 years or resection of pulmonary or liver hilus lymph node metastases the last year. * Previous diagnosed bone or CNS metastatic disease or thoracic or abdominal metastatic lymph nodes. * Previous diagnosed cancer mammae or malignant melanoma. * Non resected or palliative resection of primary CRC tumor. * Liver metastases affecting the diaphragm determined by CT-scan and/or ultrasound examination. * Liver lesion\>10cm * Three negative prognostic factors at time of randomization (CEA\>80, less than 2 years from diagnosis, diameter of largest liver lesion \>5.5cm). * Any reason why, in the opinion of the investigator, the patient should not participate.
Where this trial is running
Oslo
- Oslo University Hospital — Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Magnus Smedman, MD — Oslo University Hospital
- Study coordinator: Magnus Smedman, MD
- Email: torha@ous-hf.no
- Phone: 23026600
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.