Improving Survival of COlorectal LIver Metastases by RFA-mediated Immunostimulation
NCT ID: NCT04798898
Last Updated: 2024-12-05
Study Results
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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RECRUITING
NA
200 participants
INTERVENTIONAL
2022-11-14
2026-12-01
Brief Summary
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Detailed Description
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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:
CRLM affects around 1,600 individuals in Denmark each year. State-of-the-art treatment includes liver resection, RFA treatment, radiation therapy, and chemotherapy. Of all individuals undergoing surgery, 50% will experience local or distant recurrence of the disease within five years. Although liver resection is the gold standard, RFA treatment has evolved considerably in recent years. RFA is a parenchymal-sparing treatment for hepatic malignancies, inducing a localized coagulation necrosis of the tumor. This leads to release of tumor antigens, which activates the patients' immune system. However, many cancer cells, including those from CRLM, have the ability to hide their antigens to the patients' immune systems. Using RFA as immunostimulation prior to surgery, these antigens may become visible to the immune system, which in turn can help eradicating all tumor cells and decrease the risk of tumor recurrence. Combined, this likely improves survival.
METHODS:
220 patients with CRLM planned for surgery will be enrolled in this study. Patients will be randomized to +/- RFA treatment before surgery. Under guidance of ultrasonography, a single-electrode RFA-needle is placed in a CRLM with a diameter of at least 3 cm, which is later going to be resected. In 20 of the patients, we will draw blood samples for determination of immune status both pre- and postoperatively. All patients will be part of a work-up with regular CT-scans.
ENDPOINTS:
Disease free survival and overall survival. Secondarily, we will examine the effect of RFA treatment of tumors on the innate and adaptive immune system in 20 patients
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention (+RFA) arm
Preoperative partial RFA necrosis in the liver metastasis followed by liver resection
RFA (radiofrequency ablation)
Preoperative RFA-induced partial necrosis of the liver metastasis
Control (-RFA) arm
Liver resection
No interventions assigned to this group
Interventions
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RFA (radiofrequency ablation)
Preoperative RFA-induced partial necrosis of the liver metastasis
Eligibility Criteria
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Inclusion Criteria
* At least one tumor size \>=3cm
* Performance status 0-1
Exclusion Criteria
* Extrahepatic metastases that can not be addressed curatively
* Other malignant diseases within 5 years prior to diagnosis
* Prior RFA treatment
18 Years
99 Years
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
Rigshospitalet, Denmark
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Frank V Mortensen, MD, DMSc
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
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Aarhus University Hospital, Department of Surgery
Aarhus, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Jakob Kirkegård, MD, PhD
Role: primary
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ISCOLIM
Identifier Type: -
Identifier Source: org_study_id