Improving Survival of COlorectal LIver Metastases by RFA-mediated Immunostimulation (ISCOLIM)

University of Aarhus

Status: Enrolling

Conditions: Liver Metastasis Colon Cancer

Treatments: Device: RFA (radiofrequency ablation)

Study type: Interventional

Funder types: Other

Identifiers

NCT04798898

ISCOLIM

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Intervention (+RFA) arm

Experimental group

Description:

Preoperative partial RFA necrosis in the liver metastasis followed by liver resection

Treatment:

Device: RFA (radiofrequency ablation)

Control (-RFA) arm

No Intervention group

Description:

Liver resection