Low-dose interferon-alfa2a treatment for colon cancer patients before surgery

Effect of Low-dose Interferon-alfa2a on Peri-operative Immune Suppression

This study is testing whether a low-dose treatment called interferon-alfa2a can boost the immune response in colon cancer patients before their surgery to see if it helps improve their outcomes.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zealand University Hospital (other)
• Locations: 1 site (Herlev, Zealand)
• Trial ID: NCT04798612 on ClinicalTrials.gov

What this trial studies

This phase 2 clinical trial investigates the effects of low-dose interferon-alfa2a on immune suppression in patients with pMMR colon cancer who are scheduled for laparoscopic hemicolectomy. The study is randomized, double-blinded, and placebo-controlled, aiming to assess the efficacy of this treatment in enhancing lymphocyte infiltration in the primary tumor during the perioperative period. Participants will receive either the interferon treatment or a saline placebo to evaluate the immune response. The trial seeks to provide insights into how preoperative immunotherapy can influence surgical outcomes in colon cancer patients.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old diagnosed with pMMR colonic adenocarcinoma and scheduled for laparoscopic hemicolectomy.

Not a fit: Patients with severe comorbidities, recent major surgeries, or those on immunosuppressive therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve immune function and potentially enhance surgical outcomes for colon cancer patients.

How similar studies have performed: While similar approaches have been explored, this specific application of low-dose interferon-alfa2a in the perioperative setting for colon cancer is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Patients above 18 years of age.
* Patients diagnosed with pMMR colonic adenocarcinoma and scheduled for laparoscopic hemicolectomy.
* ASA class I-III (Classification of the American Society of Anesthesiology)

Exclusion Criteria:

* Patients with childbearing potential without a negative pregnancy test before initiating study drug and / or non-acceptance to the use of contraceptive methods \*
* ECOG score function\> / = 3
* Current liver or renal disease.
* Severe heart disease
* Previous depression diagnosed by a psychiatrist or in treatment with antidepressant
* Autoimmune disease.
* Uncontrolled thyroid disease.
* Patients who are or have recently (within 6 months) received treatment with immunosuppressive agents other than corticosteroid treatment.
* Epilepsy and / or other serious CNS disorders.
* Patients that have undergone major surgery within one month before planned colon resection.
* Known hypersensitivity to recombinant interferon or auxiliary products of Pegasys®.

  * Spiral, pill, implant, transdermal patch, vaginal ring or depot injection. Sterile / infertile subjects are exempt from the use of contraception. To be considered sterile or infertile must generally be surgical sterilization (vasectomy, bilateral tubectomy, hysterectomy or ovariectomy) or be postmenopausal, defined as absent menstruation for at least 12 months prior to study enrolment.

Where this trial is running

Herlev, Zealand

• Herlev University Hospital — Herlev, Zealand, Denmark (RECRUITING)

Study contacts

• Study coordinator: Ismail Gögenur, MD, Professor

Conditions: Colon Cancer