The Swedish Study of Liver Transplantation for Non-resectable Colorectal Cancer Metastases (NCT04161092) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Swedish Study of Liver Transplantation for Non-resectable Colorectal Cancer Metastases
Sweden45 participantsStarted 2020-12-01
Plain-language summary
To evaluate if the addition of liver transplantation primarily utilizing liver grafts from extended criteria donors not utilized for approved indications to conventional treatment of non-resectable/ non-abatable colorectal liver metastases (CLM) increases overall survival compared to best alternative care.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients with non-resectable, non-ablatable liver metastases from colorectal adenocarcinoma.
* Male or female 18 years or above.
* Primary tumour removed with an R0 resection, and histologically verified adenocarcinoma from colon or rectum
* Liver metastases measurable by MRI or CT according to RECIST version 1.1 Imaging within 4 weeks prior to inclusion.
* No signs of extrahepatic metastatic disease or local recurrence according to MRI and CT of thorax/abdomen and whole body Positron-emission tomography (PET)/ computed tomography (CT) scan.
* A colonoscopy performed within the last 12 months in order to exclude multifocal colorectal cancer (CRC) tumours.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Satisfactory blood tests: Hb ≥ 90 g/L (transfusions are permitted to achieve baseline hemoglobin level), White blood cell Count (WBC) \>3,0x109/L, Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L, platelet Count (PLT) \>75, Bilirubin\<2 x upper normal level, Aspartate aminotransferase (ASAT), Alanine aminotransferase (ALAT)\<5 x upper normal level, Calculated Creatinine clearance ≥ 50 mL/min(MDRD).
* Received at least 2 months of chemotherapy with no signs of progressive disease according to RECIST-criteria at the last evaluation before randomization.
* One year or more from the initial CRC diagnosis to the date of inclusion in the study
* Patient accepted for transplantation by a national study board
* Signed and dated written …