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

NCT ID: NCT04798612

Last Updated: 2023-08-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-14
• Study Completion Date: 2025-12-01

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 immune suppression and infiltration of lymphocytes in the primary tumor.

Conditions

Colon Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention arm

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.

Group Type: EXPERIMENTAL

Pegasys

Intervention Type: DRUG

45 mikrograms of Pegasys. Two subcutanous doses will be administered with at least 7 days in between

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

0.50 ml of Saline. Two subcutanous doses will be administered with at least 7 days in between

Interventions

Pegasys

45 mikrograms of Pegasys. Two subcutanous doses will be administered with at least 7 days in between

Intervention Type: DRUG

Saline

0.50 ml of Saline. Two subcutanous doses will be administered with at least 7 days in between

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

Zealand University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Herlev University Hospital

Herlev, Region Sjælland, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Ismail Gögenur, MD, Professor

Role: CONTACT

igo@regionsjaelland.dk

26356426 ext. 0045

Helin Yikilmaz Pardes, MD

Role: CONTACT

heyi@regionsjaelland.dk

28913473 ext. 0045

Facility Contacts

Helin Yikilmaz Pardes, MD

Role: primary

heyi@regionsjaelland.dk

28913473 ext. 0045

Other Identifiers

SJ-874

Identifier Type: -

Identifier Source: org_study_id