Improving Survival of COlorectal LIver Metastases by RFA-mediated Immunostimulation (ISCOLIM)
Study Overview
Status
Conditions
Intervention / Treatment
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:
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
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jakob Kirkegård, MD, PhD
- Phone Number: +4524995027
- Email: jakob.kirkegaard@auh.rm.dk
Study Locations
-
-
-
Aarhus, Denmark, 8200
- Recruiting
- Aarhus University Hospital, Department of Surgery
-
Contact:
- Jakob Kirkegård, MD, PhD
- Email: jakob.kirkegaard@auh.rm.dk
-
Principal Investigator:
- Frank V Mortensen, MD, DMSc
-
Sub-Investigator:
- Jakob Kirkegård, MD, PhD
-
Sub-Investigator:
- Andrea Lund, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention (+RFA) arm
Preoperative partial RFA necrosis in the liver metastasis followed by liver resection
|
Preoperative RFA-induced partial necrosis of the liver metastasis
|
|
No Intervention: Control (-RFA) arm
Liver resection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival
Time Frame: 3 years
|
Median survival in each arm
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
One-year survival
Time Frame: 1 year
|
One-year survival in each arm
|
1 year
|
|
Two-year survival
Time Frame: 2 years
|
Two-year survival in each arm
|
2 years
|
|
Three-year survival
Time Frame: 3 years
|
Three-year survival in each arm
|
3 years
|
|
Recurrence rate
Time Frame: 1, 2, and 3 years
|
Recurrence rate at 1, 2, and 3 years follow-up
|
1, 2, and 3 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Complications
Time Frame: 30-day postoperatively
|
Immediate postoperative complications (bleeding, surgical site infection, intraabdominal abscesses, bile leak)
|
30-day postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Frank V Mortensen, MD, DMSc, Aarhus University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ISCOLIM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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