Tests low-dose interferon alfa-2a around surgery in people with colon cancer
Tests low-dose interferon alfa-2a against placebo in adults having colon cancer surgery.
Key facts
- Who runs it
- Region Sjaelland
- Where
- Herlev and Koege, DenmarkSee the 2 sites
- Registry title
- Effect of low-dose Interferon-alfa2a on perioperative immune suppression
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 68 people, planned
- Started
- 28 Aug 2023
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional
- Record updated
- 20 January 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a certain type of colon cancer (pMMR colonic adenocarcinoma) who are scheduled for keyhole (laparoscopic) surgery to remove part of the colon.
- Age
- Above 18 years
- Sex
- All sexes
- Disease stage
- pMMR colonic adenocarcinoma, scheduled for laparoscopic hemicolectomy; ASA class I-III
- Earlier treatment
- Cannot have had major surgery within one month before the planned colon surgery, and cannot have had immunosuppressive medicines other than corticosteroids within 6 months.
- Biomarker or test result
- pMMR (mismatch repair proficient) colon tumour
Main reasons for not taking part
- Women who can have children and have no negative pregnancy test or will not use contraception
- ECOG score of 3 or more
- Current liver or kidney disease, severe heart disease, or autoimmune disease
- Previous depression diagnosed by a psychiatrist or treated with an antidepressant
- Epilepsy or other serious brain and nerve disorders
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- Patients above 18 years of age. 2. Patients diagnosed with pMMR colonic adenocarcinoma and scheduled for laparoscopic hemicolectomy. 3. ASA class I-III (Classification of the American Society of Anesthesiology)
Who cannot take part
- 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 in Denmark
- Region HovedstadenHerlev, DenmarkTaking people
- Region SjaellandKoege, DenmarkTaking people
About the trial
What the trial wants to find out
1. Differences in measures of lymphocytic subpopulations (FLOW) between intervention and placebo group, seen as a higher number of CD3, 4, 8 and HLA-positive cells in the intervention group, on the day of and the day after surgery.
Read full original descriptionShow less
2. Differences in tumor-infiltrating lymphocytes in the resected specimen at the tumor center and invasive margin between the intervention and placebo group. This will be analysed via immunohistochemistry with staining for CD3+, CD4+ and CD8+ T-cells.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- Effect of low-dose Interferon-alfa2a on perioperative immune suppression
- Plain-language title
- Tests low-dose interferon alfa-2a around surgery in people with colon cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 20 January 2026