Effect of low-dose Interferon-alfa2a on perioperative immune suppression
Key facts
- Where
- Herlev és Koege, DániaSee the 2 sites
- Phase
- 2. fázis
Where in Dánia
- Region HovedstadenHerlev, DániaTaking people
- Region SjaellandKoege, DániaTaking people
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?
Trial details
- Who runs it
- Region Sjaelland
- Trial code
- EU 2024-517619-65-00
- Record updated
- 2026. január 20.
- Original description
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
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.
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.
Inclusion: 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).
Exclusion: 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.