NCT04798898RecruitingNot Applicable
Improving Survival of COlorectal LIver Metastases by RFA-mediated Immunostimulation
University of Aarhus2 sites in 1 country200 target enrollmentStarted: November 14, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Aarhus
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Overall survival
Study Overview
Brief Summary
To examine radio frequency ablation as a treatment supplement to stimulate immunogenicity and improve survival for patients undergoing curative-intent surgery for colorectal liver metastases.
Detailed Description
PURPOSE:
To investigate the impact of immunostimulation using radio frequency ablation (RFA) on survival in patients undergoing curative-intent surgery for colorectal liver metastases (CRLM).
HYPOTHESIS:
RFA-mediated partial destruction of CRLM will stimulate the immune system to recognize otherwise hidden cancer antigens, which in turn will improve survival by inhibiting micrometastases and recurrence.
BACKGROUND:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with colorectal liver metastases planned for resection
- •At least one tumor size >=3cm
- •Performance status 0-1
Exclusion Criteria
- •Liver cirrhosis
- •Extrahepatic metastases that can not be addressed curatively
- •Other malignant diseases within 5 years prior to diagnosis
- •Prior RFA treatment
Outcomes
Primary Outcomes
Overall survival
Time Frame: 3 years
Median survival in each arm
Secondary Outcomes
- One-year survival(1 year)
- Recurrence rate(1, 2, and 3 years)
- Two-year survival(2 years)
- Three-year survival(3 years)
Investigators
Study Sites (2)
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