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

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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 immune suppression and infiltration of lymphocytes in the primary tumor.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zealand University Hospital
• Treatments: Peginterferon alfa-2a

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.