NCT02215889 Partial Liver Segment 2/3 Transplantation Study
| NCT ID | NCT02215889 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Oslo University Hospital |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2014-06 |
| Primary Completion | 2025-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2014-06 with a primary completion date of 2025-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The patients will receive hepatectomy as a 2 stage procedure. In the first surgical procedure liver segments 2-3 are removed and liver donor segments 2-3 inserted. After growth of donor segments 2-3, the remaining liver segments of the recipient are removed. The patient will at this time have only donor liver tissue in place.
Eligibility 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 4 weeks prior to the faculty meeting at the transplant unit, except patients may have 1-3 resectable lung lesions all\<15mm. * No signs of extra hepatic metastatic disease on CT thorax/abdomen/pelvis within 4 weeks prior to the faculty meeting at the transplant unit, except patients may have 1-3 resectable lung lesions all\<15mm. * No local recurrence according to MR-pelvis scan in patients with rectal cancer within 4 weeks prior to the faculty meeting at the transplant unit * No signs of local recurrence judged by colonoscopy / CT colography within 12 months prior to the faculty meeting at the transplant unit * Good performance status, ECOG 0 or 1. * Satisfactory blood tests: Hb \>10g/dl, neutrophiles \>1.0 (after any G-CSF), TRC \>75, Bilirubin\<2 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 follow up must be obtained and documented according to GCP, and national/local regulations. * All patients should have received at least 8 weeks of chemotherapy. Exclusion Criteria: * Weight loss \>10% the last 6 months * Patient BMI \> 30 * Previous diagnosed bone or CNS metastatic disease. * Previous diagnosed cancer mammae or malignant melanoma. * Palliative resection of primary CRC tumor.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT02215889 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02215889 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT02215889 currently recruiting?
Yes, NCT02215889 is actively recruiting participants. Contact the research team at torha@ous-hf.no for enrollment information.
Where is the NCT02215889 trial being conducted?
This trial is being conducted at Oslo, Norway.
Who is sponsoring the NCT02215889 clinical trial?
NCT02215889 is sponsored by Oslo University Hospital. The trial plans to enroll 20 participants.
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