Clinical trial · Interventional
Effect of Low-dose Interferon-alfa2a on Peri-operative Immune Suppression
NCT04798612CI-TRIAL-00068889IPOSunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this randomized double-blinded placebo-controlled phase 2 study is to determine efficacy of preoperative treatment with interferon-alfa2a in patients with pMMR colon cancer on perioperative immune suppression and infiltration of lymphocytes in the primary tumor.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pegasys | Drug | Peginterferon Alfa-2a | ALIAS |
| Saline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention arm
- description
- Two 45 mikrogram doses of interferon-alfa2a (Pegasys). Both will be applied subcutanously. First dose is at least one week before surgery. Second dose on the day of surgery before the procedure.
- interventionNames
- Drug: Pegasys
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Two 1 ml doses of saline liquid. Both will be applied subcutanously. First dose is at least one week before surgery. Second dose on the day of surgery before the procedure.
- interventionNames
- Drug: Saline
Primary outcomes (2)
- measure
- Flow-analysis of lymphocytic subpopulations in blood
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.