Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001208594
Ethics application status
Approved
Date submitted
26/06/2024
Date registered
1/10/2024
Date last updated
1/10/2024
Date data sharing statement initially provided
1/10/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Liver Transplantation for Unresectable ColoRectal Liver Metastases
Scientific title
Assessment of Long-term survival after Liver Transplantation for Unresectable ColoRectal Liver Metastases
Secondary ID [1] 312410 0
none
Universal Trial Number (UTN)
Trial acronym
LT-CLM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer 334220 0
colorectal 334221 0
Condition category
Condition code
Cancer 330891 330891 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of the study is to see whether selected patients with isolated liver metastases may benefit from liver transplantation.

Liver transplantation is an intervention that participants receive as part of this study.
The liver transplant surgery itself usually takes around 4 to 6 hours, depending on the complexity of the case. During the procedure, the diseased liver is removed, and a healthy donor liver is transplanted. Surgery consist in liver transplantation, removal of the receipient liver containing colorectal liver metastases with a liver from a living donor or deceased donor.
After surgery, the patient is transferred to the Intensive Care Unit (ICU) for close monitoring, typically for 1-2 days, to ensure the new liver is functioning well and to manage pain or any complications. The total hospital stay is generally around 7 to 10 days, during which the patient will receive post-operative care, medication to prevent rejection, and guidance on recovery. After discharge, regular follow-up appointments and blood tests are essential to monitor the liver function and overall recovery.

Surgery is performed by liver transplant surgeons at RPA hospital. Liver transplant is a standard procedure here in Australia and the rest of world. No specific pre-post sugery requirements.
Intervention code [1] 328912 0
Treatment: Surgery
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338647 0
To assess if selected patients with unresectable colorectal metastases can achieve long-term survival with liver transplant
Timepoint [1] 338647 0
1year, 3year and 5year (primary endpoint) survival post transplantation
Secondary outcome [1] 436806 0
Assess tumour recurrence
Timepoint [1] 436806 0
1-3-5 year disease free after liver transplant
Secondary outcome [2] 439169 0
Graft Survival
Timepoint [2] 439169 0
1-3-5 year after transplantation
Secondary outcome [3] 439171 0
Quality of life
Timepoint [3] 439171 0
1-3-5 years after liver transplant
Secondary outcome [4] 439665 0
Tumor pathology
Timepoint [4] 439665 0
Examination performed after liver transplant operation
Secondary outcome [5] 439666 0
90-days Postoperative complication
Timepoint [5] 439666 0
Assessed at 90 days after transplant

Eligibility
Key inclusion criteria
• Adult from 18 to 60 years old, male of female
• Able to consent
• Unresectability confirmed by at least 2 Hepatobiliary surgeons based on good quality cross sectional imaging (CT and or MRI).
• Time from primary colorectal diagnosis to transplant is >6 months
• Primary Colorectal cancer (CRC) tumour stage is <T4a
• The patient has undergone appropriate modern systemic chemotherapy +/- monoclonal antibody (eg. FOLFOX +/bevacizumab or FOLFIRI +/- bevacizumab) for >3 months
• Demonstrated stability or regression of LM over at minimum the 3 months preceding screening
• Not rising CEA in the preceding three months period
• Performance status, ECOG 0
• Patients otherwise suitable for liver transplantation.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with extrahepatic metastases (other than resectable lung metastases or low risk primary cancer).
• BRAF mutation
• MSI high and/or MMR deficient tumours (should be considered for immunotherapy with checkpoint inhibitors rather than LT).
• Significant comorbidities or behaviours that preclude transplantation
• There is a tumor progression in the preceding 3 months
• Known history of human immunodeficiency virus (HIV) infection
• Renal dysfunction with an estimated creatinine clearance of less than 50 ml/min
• Unresectaed primary tumour
• Tumour thrombus
• Patients otherwise not suitable for liver transplantation

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The cumulative incidence of recurrence and Cancer-specific death were evaluated by competing risk analysis.
The standard Cox proportional hazard model will be used when there are no competing events, to model cause-specific hazards as proposed by Prentice et al.

In order to account for the impact of competing risks, we will use the subdistribution hazard model approach proposed by Fine and Gray. This approach uses cumulative incidence function to accurately estimate marginal probability of an event in the presence of competing events.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/08/2023
Date of last participant enrolment
Anticipated
3/06/2028
Actual
Date of last data collection
Anticipated
3/06/2033
Actual
Sample size
Target
30
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 26732 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 42779 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 316821 0
Hospital
Name [1] 316821 0
Royal Prince Alfred Hospital
Country [1] 316821 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 319050 0
None
Name [1] 319050 0
Address [1] 319050 0
Country [1] 319050 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315591 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 315591 0
Ethics committee country [1] 315591 0
Australia
Date submitted for ethics approval [1] 315591 0
16/06/2023
Approval date [1] 315591 0
15/12/2023
Ethics approval number [1] 315591 0
2023/eth01337

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135170 0
A/Prof Carlo Pulitano
Address 135170 0
Royal Prince Alfred Hospital, 50 Missenden Rd, Camperdown NSW 2050
Country 135170 0
Australia
Phone 135170 0
+61 02 95172020
Fax 135170 0
Email 135170 0
Carlo.pulitano@sydney.edu.au
Contact person for public queries
Name 135171 0
Carlo Pulitano
Address 135171 0
Royal Prince Alfred Hospital, 50 Missenden Rd, Camperdown NSW 2050
Country 135171 0
Australia
Phone 135171 0
+61 02 95172020
Fax 135171 0
Email 135171 0
Carlo.pulitano@sydney.edu.au
Contact person for scientific queries
Name 135172 0
Carlo Pulitano
Address 135172 0
Royal Prince Alfred Hospital,, 50 Missenden Rd, Camperdown NSW 2050
Country 135172 0
Australia
Phone 135172 0
+61 02 95172020
Fax 135172 0
Email 135172 0
Carlo.pulitano@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
demographic, concologic, outcome
When will data be available (start and end dates)?
Data available from 1/01/2025 with no end date
Available to whom?
Other researcher
Available for what types of analyses?
Scientific analysis, survival
How or where can data be obtained?
carlo.pulitano@sydney.edu.au


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.