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

NCT04798612 | Unknown Phase 2 DMC

• 1 other identifier: SJ-874
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Flow-analysis of lymphocytic subpopulations in blood

  Change in CD3, CD4, and CD8 between intervention and placebo groups

  Change between day of surgery (day 7-14 after first treatment) and postoperative day 1.

• T-cell infiltration in tumor

  Difference in CD3, CD4 and CD8 T-cell infiltration between intervention and placebo groups

  Day of surgery (day 7-14 after first treatment)

Secondary Outcomes (6)

• Quality of recovery (QoR-15)

  Third postoperative day and postoperative day 12-16

• Multiplex gene assay - NanoString Pan Cancer 360 IO panel analysis in blood and resected tumor

  Day of first treatment (Day 0) and day of surgery (day 7-14 after first treatment)

• cfDNA analysis in blood

  Day of first treatment (Day 0), day of surgery (day 7-14 after first treatment), postoperative day 2, postoperative day 12-16, and postoperative day 28-32.

• Multiplex gene assay - NanoString Pan Cancer 360 IO panel analysis of tumor biopsy and resected specimen

  Day of standard endoscopic biopsy (Day -7-14 before treatment) and day of surgery (day 7-14 after first treatment)

• CRP and neutrophil/lymphocyte ratio

  Day of surgery (day 7-14 after first treatment)

Study Arms (2)

Intervention arm

EXPERIMENTAL

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.

Drug: Pegasys

Placebo

PLACEBO COMPARATOR

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.

Drug: Saline

Interventions

Pegasys DRUG

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

Intervention arm

Saline DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zealand University Hospital: lead
• University of Copenhagen: collaborator

Study Sites (1)

Herlev University Hospital

Herlev, Region Sjælland, 2730, Denmark

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

peginterferon alfa-2a; Sodium Chloride

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Ismail Gögenur, MD, Professor

CONTACT

26356426; igo@regionsjaelland.dk

Helin Yikilmaz Pardes, MD

CONTACT

28913473; heyi@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blinded placebo-controlled phase 2 study.

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 15, 2021
• Study Start: August 14, 2023
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 18, 2023

Record last verified: 2023-08

Locations

DK (1)