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Liver Transplantation Compared to Chemotherapy in Patients With ColoRectal Cancer | Clinical Trials | Clareo Health

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Liver Transplantation Compared to Chemotherapy in Patients With ColoRectal Cancer

A Randomized Clinical Trial Comparing Overall Survival in Selected Patients With ColoRectal Carcinoma Treated by Liver Transplantation or Chemotherapy

NCT03494946•Oslo University Hospital

View on ClinicalTrials.gov

Summary

The trial is a randomized control trial. Patients are randomized between Ltx and other treatment that may include further chemotherapy, TACE, SIRT or other available treatment options. The patients will be randomized 1:1 to Ltx and chemotherapy/other treatment options.

Detailed Description

Patients with non-resectable CRC liver metastases evaluated at the liver MDT at Oslo University Hospital, Rikshospitalet will be included in the study. Patients should have progressive disease on 1.line chemotherapy or the treatment should have been stopped due to toxicity. Patients randomized to Ltx will if applicable stop bevazicumab. All patients (both arms) will start further treatment that may include chemotherapy, TACE, SIRT or other available treatment options. Patients not receiving a donor liver graft within 3 months after listing for transplantation will be taken off the waiting list and transferred to the chemotherapy/other treatment option group. Patients randomized to Ltx and developing progressive disease beyond the inclusion/exclusion criteria during the time on the waiting list will be excluded from the study and receive best treatment option at the discretion of the treating physician.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Oslo University Hospital

Oslo, Norway

Key Dates

Start Date

December 5, 2016

Primary Completion Date

January 1, 2027

Completion Date

January 1, 2027

Last Updated

February 6, 2024

Enrollment

ESTIMATED participants

Conditions

Liver MetastasesColorectal Cancer

Interventions

Liver transplantation

PROCEDURE

Chemotherapy

DRUG

Contacts

Magnus Smedman, MD

CONTACT

23026600 torha@ous-hf.no

Maria Gjerde

CONTACT

+4723070000 mgjerde@ous-hf.no

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Liver Transplantation Compared to Chemotherapy in Patients With ColoRectal Cancer

Inclusion Criteria

Exclusion Criteria

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