The Swedish Study of Liver Transplantation for Non-resectable Colorectal Cancer Metastases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2030-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Colorectal Cancer Liver Metastases Colorectal Liver Metastases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Liver transplantation + best alternative care

Patients subjected to Ltx will during the waiting time receive individualized chemotherapy, with the aim to avoid side effect that make them not transplantable.

If possible, patients randomized to Ltx should be treated within 12 weeks after randomization.

If the patients progress systemically they will be treated with best alternative care.

If they progress only within the liver they continue to be transplantable until they are deemed technically not transplantable by the transplant surgeon.

Group Type OTHER

Liver transplantation Ltx

Intervention Type PROCEDURE

Patients will be treated with Ltx at Sahlgrenska University Hospital, Göteborg, or Karolinska University Hospital, Huddinge.

Best alternative care

The treating physician will together with the patient decide the treatment.

Group Type OTHER

Best alternative care

Intervention Type OTHER

All available treatments as well as other experimental treatments are tolerated, however no cross-over to other arm will be allowed.

Interventions

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Liver transplantation Ltx

Patients will be treated with Ltx at Sahlgrenska University Hospital, Göteborg, or Karolinska University Hospital, Huddinge.

Intervention Type PROCEDURE

Best alternative care

All available treatments as well as other experimental treatments are tolerated, however no cross-over to other arm will be allowed.

Intervention Type OTHER

Eligibility Criteria

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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 informed consent before the start of specific protocol procedures.

Exclusion Criteria

* Evidence of extrahepatic disease by PET-CT or CT-thorax/abdomen.
* Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study.
* Weight loss \>10% the last 6 months
* Other malignancies within the last 5 years, except CRC and low risk tumours such as basaliomas.

\* Liver metastases larger than 10 cm.
* Pathological lymphatic nodes in the abdomen. If a patient has pathological lymphatic nodules in the hepatoduodenal ligament, a staging operation with histo-pathological examination from the nodules with no signs of tumour cell involvement has to be performed before inclusion.
* BRAF (a gene that encodes a protein called b-raf) mutation in primary tumour
* microsatellite instability (MSI-H) in primary tumour
* Previous organ transplantation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No