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

Zealand University Hospital

Status and phase: Enrolling; Phase 2

Conditions: Colon Cancer

Treatments: Drug: Pegasys; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04798612

SJ-874

Details and patient eligibility

About

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.

Enrollment: 68 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups, including a placebo group

Intervention arm

Experimental group

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.

Treatment:

Drug: Pegasys

Placebo

Placebo Comparator group

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.

Treatment:

Drug: Saline