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Colorectal CancerSOULMATENCT04161092

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

A study testing Liver transplantation Ltx and Best alternative care in people with Colorectal Cancer and Liver Metastases, run by Vastra Gotaland Region at 2 sites in Sweden.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Liver transplantation Ltx and Best alternative care
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
2 sitesSweden
Study dates
1 Dec 2020to Jun 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • BRAF (a gene that encodes a protein called b-raf) mutation in primary tumour
  • microsatellite instability (MSI-H) in primary tumour
  • Previous organ transplantation

Trial locations and contacts

2 sites in 1 country.

Sweden2 sites

  • Transplant Institute, Sahlgrenska University Hospital

    Gothenburg

  • Transplantation Unit, Karolinska University Hospital

    Stockholm

Other trials in Sweden

About this study

Official title: A Randomized Controlled, Open-label, Multicentre Study Evaluating if Liver Transplantation With Liver Grafts From Extended Criteria Donors Not Utilised for Approved Indications Increases Overall Survival in Patients With Non-resectable Isolated Liver Metastases From Colorectal Metastases, in Comparison With Best Alternative Care

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.

Being tested
Liver transplantation Ltx, Best alternative care
Keywords
colorectal cancer, liver metastases, liver transplant, non-resectable colorectal cancer metastases
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liver transplantation LtxProcedure or surgery

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

  • Best alternative careOther

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

Study groups in NCT04161092
Study groupRoleWhat they receive
Liver transplantation + best alternative careOtherPatients 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.
Receives: Procedure: Liver transplantation Ltx
Best alternative careOtherThe treating physician will together with the patient decide the treatment.
Receives: Other: Best alternative care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Five-year overall survival

    Percentage of subject who reach the endpoint of overall survival

    Measured: randomization to follow up at 5 years

Secondary outcomes (7)

  1. Two-year overall survival

    Percentage of subject who reach the endpoint of overall survival

    Measured: randomization to follow up at 2 years

  2. Median overall survival

    Defined as time to death

    Measured: : Date of randomization until the date of death from any cause, assessed up to 5 years

  3. Progression-free survival

    Defined as time from randomization to progress of existing lesions, or appearance of new lesions, within the liver according to RECIST criteria (version 1.1) using CT or MRI and analysed using Kaplan-Meier and the log-rank test.

    Measured: Date of randomization until the date of documented progression of existing lesions or appearance of new lesions, assessed up to 5 years

  4. Hepatic progression-free survival

    Defined as time from randomization to progress of existing lesions in the liver , or appearance of new lesions in the liver, according to RECIST criteria (version 1.1) using CT or MRI and analysed using Kaplan-Meier and the log-rank test.

    Measured: Date of randomization until the date of documented progression of existing lesions or appearance of new lesions in the liver, assessed up to 5 years

  5. Extrahepatic recurrence-free survival

    Defined as time from randomization to appearance of new extra-hepatic lesions, using CT or MRI and analysed using Kaplan-Meier and the log-rank test.

    Measured: Date of randomization until the date of documented appearance of new extra-hepatic lesions, assessed up to 5 years

  6. Changes in quality of Life assessed with Euroqol Group Questionaire 5D-3L (EQ-5D-3L)

    Assessed with EQ-5D-3L

    Measured: baseline, 3, 6, 12, 18, 24, 36 and 60 months

  7. Health economic evaluation

    Estimation of Quality Adjusted Life Year (QALY) assessed with EQ-5D-3L

    Measured: baseline, 3, 6, 12, 18, 24, 36 and 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2019
  2. Study start1 Dec 2020
  3. Primary completionDec 2029 (estimated)
  4. Study completionJun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04161092
Sponsor's protocol ID
SOULMATE
Acronym
SOULMATE
Status last verified
Oct 2024
First submitted
31 Oct 2019
Last updated
28 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Abdalla EK, Vauthey JN, Ellis LM, Ellis V, Pollock R, Broglio KR, Hess K, Curley SA. Recurrence and outcomes following hepatic resection, radiofrequency ablation, and combined resection/ablation for colorectal liver metastases. Ann Surg. 2004 Jun;239(6):818-25; discussion 825-7. doi: 10.1097/01.sla.0000128305.90650.71.

    PubMed 15166961

  • Hagness M, Foss A, Line PD, Scholz T, Jorgensen PF, Fosby B, Boberg KM, Mathisen O, Gladhaug IP, Egge TS, Solberg S, Hausken J, Dueland S. Liver transplantation for nonresectable liver metastases from colorectal cancer. Ann Surg. 2013 May;257(5):800-6. doi: 10.1097/SLA.0b013e3182823957.

    PubMed 23360920

  • Dueland S, Guren TK, Hagness M, Glimelius B, Line PD, Pfeiffer P, Foss A, Tveit KM. Chemotherapy or liver transplantation for nonresectable liver metastases from colorectal cancer? Ann Surg. 2015 May;261(5):956-60. doi: 10.1097/SLA.0000000000000786.

    PubMed 24950280

  • Gorgen A, Muaddi H, Zhang W, McGilvray I, Gallinger S, Sapisochin G. The New Era of Transplant Oncology: Liver Transplantation for Nonresectable Colorectal Cancer Liver Metastases. Can J Gastroenterol Hepatol. 2018 Jan 10;2018:9531925. doi: 10.1155/2018/9531925. eCollection 2018.

    PubMed 29623268

  • Fosby B, Melum E, Bjoro K, Bennet W, Rasmussen A, Andersen IM, Castedal M, Olausson M, Wibeck C, Gotlieb M, Gjertsen H, Toivonen L, Foss S, Makisalo H, Nordin A, Sanengen T, Bergquist A, Larsson ME, Soderdahl G, Nowak G, Boberg KM, Isoniemi H, Keiding S, Foss A, Line PD, Friman S, Schrumpf E, Ericzon BG, Hockerstedt K, Karlsen TH. Liver transplantation in the Nordic countries - An intention to treat and post-transplant analysis from The Nordic Liver Transplant Registry 1982-2013. Scand J Gastroenterol. 2015 Jun;50(6):797-808. doi: 10.3109/00365521.2015.1036359.

    PubMed 25959101

  • Reivell V, Hagman H, Haux J, Jorns C, Lindner P, Taflin H. SOULMATE: the Swedish study of liver transplantation for isolated colorectal cancer liver metastases not suitable for operation or ablation, compared to best established treatment-a randomized controlled multicenter trial. Trials. 2022 Sep 30;23(1):831. doi: 10.1186/s13063-022-06778-9.

    PubMed 36180944

Questions about this trial

What is this clinical trial studying?

A study testing Liver transplantation Ltx and Best alternative care in people with Colorectal Cancer and Liver Metastases, run by Vastra Gotaland Region at 2 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Five-year overall survival (time frame: randomization to follow up at 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04161092, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.

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