Improving Survival of COlorectal LIver Metastases by RFA-mediated Immunostimulation

Liver Metastasis Colon Cancer Clinical Trial

— ISCOLIM  

Official title:

Improving Survival of COlorectal LIver Metastases by RFA-mediated Immunostimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04798898
• Other study ID #: ISCOLIM
• Status: Recruiting
• Phase: N/A
• Start date: November 14, 2022
• Est. completion date: December 1, 2026

Study information

• Verified date: November 2023
• Source: University of Aarhus
• Contact: Jakob Kirkegård, MD, PhD
• Phone: +4524995027
• Email: jakob.kirkegaard[@]auh.rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Metastasis Colon Cancer
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Device:
• RFA (radiofrequency ablation)
Preoperative RFA-induced partial necrosis of the liver metastasis

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Department of Surgery	Aarhus

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications	Immediate postoperative complications (bleeding, surgical site infection, intraabdominal abscesses, bile leak)	30-day postoperatively
Primary	Overall survival	Median survival in each arm	3 years
Secondary	One-year survival	One-year survival in each arm	1 year
Secondary	Two-year survival	Two-year survival in each arm	2 years
Secondary	Three-year survival	Three-year survival in each arm	3 years
Secondary	Recurrence rate	Recurrence rate at 1, 2, and 3 years follow-up	1, 2, and 3 years