An interventional study of RFA (radiofrequency ablation) in Liver Metastasis Colon Cancer, sponsored by University of Aarhus. Recruiting at 1 site in Denmark. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment
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.
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
University of Aarhus is the lead sponsor of 1,299 studies on the registry; 189 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Preoperative partial RFA necrosis in the liver metastasis followed by liver resection
Device: RFA (radiofrequency ablation)
Liver resection
Preoperative RFA-induced partial necrosis of the liver metastasis
Overall survival
Median survival in each arm
Time frame: 3 years
One-year survival
One-year survival in each arm
Time frame: 1 year
Two-year survival
Two-year survival in each arm
Time frame: 2 years
Three-year survival
Three-year survival in each arm
Time frame: 3 years
Recurrence rate
Recurrence rate at 1, 2, and 3 years follow-up
Time frame: 1, 2, and 3 years
Complications
Immediate postoperative complications (bleeding, surgical site infection, intraabdominal abscesses, bile leak)
Time frame: 30-day postoperatively
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.