Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001333606p
Ethics application status
Submitted, not yet approved
Date submitted
23/11/2023
Date registered
19/12/2023
Date last updated
23/06/2024
Date data sharing statement initially provided
19/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the efficacy of an Adjuvant immunotherapy for preventing colorectal liver metastases - The CCaLM trial
Scientific title
The Novel use of Labetuzumab as Adjuvant Immunotherapy in Patients with Primary Colon Adenocarcinoma with Intact PELPK Binding Motif in their CEACAM5 gene in a Phase II clinical trial regarding the Development of Metachronous Liver Metastases (i.e., those at ‘high-risk’ of metachronous CRCLMs)
Secondary ID [1] 311019 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CCaLM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colon cancer 332137 0
Condition category
Condition code
Oral and Gastrointestinal 328859 328859 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 328969 328969 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Labetuzumab in Normal saline for the intervention group (in those patient's who are at higher risk of liver metastases from colon cancer - i.e., have an intact or test positive for the CEA PELPK region)
Dosage: 8mg/kg via an intravenous infusion once a week over a three-week period (three doses in total), commencing 6 weeks after surgical resection.
NB: There are no current strategies planned to be used to monitor adherence (as these aren't available currently)
Risk of liver metastases with be determined for each patient by having their primary tumour tested via genetic sequencing of the CEA PELPK region - If intact; they will be classed as 'higher-risk' and if it is mutant variant then they will be classed as 'lower risk;' - These will occur after primary resection as the resected specimen is required for the test.
There will also be a non-active participant group who are at lower risk of liver metastases - apart from being involved in the trial for the purposes of having their primary resected tumour tissue being sent for CEA PELPK region genetic sequencing (which would have been negative or mutant) they will be purely observed as per the Cancer Council Australia CR guidelines - and will not be further involved in the Labetuzumab vs placebo RCT part of the trial
Intervention code [1] 327466 0
Treatment: Drugs
Comparator / control treatment
Normal saline only for the placebo group (in those patient's who are at higher risk of liver metastases from colon cancer - i.e., have an intact or test positive for the CEA PELPK region)
Control group
Placebo

Outcomes
Primary outcome [1] 336659 0
Development of metachronous (> 6 months from primary operation) liver metastases related to their primary colon cancer
Timepoint [1] 336659 0
At 1, 3, 6 then 12 months post operatively, then 6 monthly for 2 years and they yearly for 3 years for a total of at least 5 years; in line with the colorectal cancer guidelines from cancer Australia
Secondary outcome [1] 429209 0
Development of metachronous (> 6 months from primary operation) liver metastases related to their primary colon cancer in patients who test negative or have a mutated CEA PELPK region (will be in the non-active participant group)
Timepoint [1] 429209 0
1, 3, 6 and 12 months post operatively, then 6 monthly for 2 years and then yearly for 3 years for a total of at least 5 years

Eligibility
Key inclusion criteria
Patients with suspected or confirmed colon adenocarcinoma (on histopathology) who are undergoing surgical resection at St George Hospital, Sydney
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those who would be beyond 6 weeks post-operatively or had previous bowel cancer/resections.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other
Other design features
Those who have an intact CEA PELPK region (confirmed via genetic sequencing of primary tumour tissue; or when available an immunohistochemistry test) will enter into the RCT side of the trial; Patients who are enrolled but have a mutated CEA PELPK region with be purely observed to see if they develop metachronous liver metastases during their usual follow-up (non-intervention arm)
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Chi square between intervention and placebo group and those that do or do not go on to develop metachronous liver metastases

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25882 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 41715 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 315281 0
Hospital
Name [1] 315281 0
St George Hospital (Trust Fund - Prof David Morris)
Country [1] 315281 0
Australia
Primary sponsor type
Hospital
Name
St George Hospital
Address
Short Street, Kogarah, Sydney, NSW, 2217
Country
Australia
Secondary sponsor category [1] 317321 0
None
Name [1] 317321 0
Address [1] 317321 0
Country [1] 317321 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314202 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 314202 0
Ethics committee country [1] 314202 0
Australia
Date submitted for ethics approval [1] 314202 0
23/11/2023
Approval date [1] 314202 0
Ethics approval number [1] 314202 0

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

Contacts
Principal investigator
Name 130770 0
Dr Adam Cristaudo
Address 130770 0
Pitney Building, SHort Street, St George Hospital, Kogarah, NSW, 2217
Country 130770 0
Australia
Phone 130770 0
+61 291131493
Fax 130770 0
Email 130770 0
[email protected]
Contact person for public queries
Name 130771 0
Adam Cristaudo
Address 130771 0
Pitney Building, SHort Street, St George Hospital, Kogarah, NSW, 2217
Country 130771 0
Australia
Phone 130771 0
+61 291131493
Fax 130771 0
Email 130771 0
[email protected]
Contact person for scientific queries
Name 130772 0
Adam Cristaudo
Address 130772 0
Pitney Building, SHort Street, St George Hospital, Kogarah, NSW, 2217
Country 130772 0
Australia
Phone 130772 0
+61 291131493
Fax 130772 0
Email 130772 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.