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A study of peginterferon alfa-2a to improve immune system function during colon cancer surgery

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with colon cancer who are scheduled for surgery. The study examines how Peginterferon alfa-2a (also known as Pegasys) affects the immune system during and after the surgical procedure. The medication is given through subcutaneous injection, which means it is injected under the skin.

The study compares two groups of patients - one receiving Peginterferon alfa-2a and another receiving placebo. The treatment involves giving the medication at specific doses before and after the surgical procedure. During the study, patients will receive either the study medication or placebo for up to 14 days. The study also includes the use of sodium chloride solution as part of the treatment.

The main purpose of this research is to understand how this medication affects certain immune cells in the body and within the tumor tissue during the surgical period. The study will examine how the immune system responds to the treatment by looking at different types of immune cells in both the blood and the removed tumor tissue.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive a subcutaneous injection (under the skin) of either Pegasys (peginterferon alfa-2a) or a placebo solution

    The injection contains 135 micrograms of the medication in a pre-filled syringe

    This treatment is administered before your scheduled laparoscopic hemicolectomy (minimally invasive colon surgery)

  2. Step 2

    Surgery day

    Blood samples will be collected to analyze your immune cell levels

    Your scheduled laparoscopic hemicolectomy will be performed

    During surgery, you will receive standard sodium chloride solution (saline) through an intravenous line

  3. Step 3

    Day after surgery

    Additional blood samples will be collected to monitor immune cell levels

    Your recovery will be monitored by medical staff

  4. Step 4

    Third post-operative day

    You will complete a Quality of Recovery questionnaire about your recovery experience

  5. Step 5

    12-16 days after surgery

    Final Quality of Recovery questionnaire completion

    Assessment of your recovery progress

  6. Step 6

    Follow-up period

    Regular monitoring until the study conclusion in December 2026

    Analysis of tissue samples from surgery will be performed to study immune cell patterns

Who can join the trial?

7 criteria

  • You must be 18 years or older
  • You must be diagnosed with colon cancer specifically of the type called pMMR colonic adenocarcinoma (a common type of colon cancer that has normal DNA repair mechanisms)
  • You must be scheduled for laparoscopic hemicolectomy (a minimally invasive surgery to remove part of the colon)
  • Your physical health status must fall within ASA class I-III (a scale used by doctors to assess a patient's health before surgery, where:
    • Class I means you are healthy
    • Class II means you have mild systemic disease
    • Class III means you have severe systemic disease)
    • Both men and women can participate

Who cannot join the trial?

13 criteria

  • Age below 18 years or above 65 years
  • Known allergy or hypersensitivity to study medications
  • Currently participating in other clinical trials
  • Previous surgery for colon cancer
  • History of other cancers in the past 5 years (except non-melanoma skin cancer)
  • Severe heart, liver, or kidney disease
  • Active infection or fever
  • Pregnancy or breastfeeding
  • Use of immunosuppressive medications (drugs that weaken the immune system)
  • Autoimmune diseases (conditions where the immune system attacks the body's own tissues)
  • Mental conditions that could affect ability to provide informed consent
  • Blood disorders or abnormal blood cell counts
  • Inability to follow study procedures
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Investigated drugs

Interferon-alfa2a is a medication that helps boost the immune system. It belongs to a group of proteins called interferons that naturally occur in the body. In this trial, it is used in a low dose to prevent the weakening of the immune system that typically occurs during and after surgery. The medication works by helping to maintain the number and function of important immune cells, particularly different types of white blood cells that help fight diseases.

What is already known about the treatment

Interferon-alfa2a – A therapeutic protein administered through subcutaneous or intramuscular injection, which belongs to the class of biological response modifiers. This medication is widely used in oncology, particularly in the treatment of various cancers including colon cancer, where it helps enhance the body's immune response against cancer cells. Interferon-alfa2a works by stimulating the immune system, specifically by increasing the activity of natural killer cells and T-lymphocytes (CD3, CD4, and CD8 cells), while also having direct anti-proliferative effects on tumor cells. The medication is classified as a cytokine immunomodulator and is particularly notable for its ability to reduce perioperative immune suppression that commonly occurs during cancer surgery.

Investigated diseases

Colon Cancer - A disease that begins in the large intestine (colon), where healthy cells in the colon start to grow uncontrollably. It typically starts as small, benign clumps of cells called polyps that form on the inner lining of the colon. Over time, some of these polyps can develop into colon cancer. The disease usually develops slowly, which means it takes several years for a polyp to transform into cancer. As the condition progresses, cancer cells can grow through the layers of the colon wall and potentially spread to nearby structures or other parts of the body. The cancer can affect any part of the colon, which is the final part of the digestive tract before the rectum.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517619-65-00Estimated enrolment68 patientsSponsorRegion Sjaelland

sourced from the EU Clinical Trials Register and site verification

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