Status:
UNKNOWN
Effect of Low-dose Interferon-alfa2a on Peri-operative Immune Suppression
Lead Sponsor:
Zealand University Hospital
Collaborating Sponsors:
University of Copenhagen
Conditions:
Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04798612
Start Date
August 14 2023
End Date
December 1 2025
Last Update
August 18 2023
Active Locations (1)
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1
Herlev University Hospital
Herlev, Region Sjælland, Denmark, 2730