Clinical trial NCT04798612: Effect of Low-dose Interferon-alfa2a on Peri-operative Immune Suppression
Official title: Effect of Low-dose Interferon-alfa2a on Peri-operative Immune Suppression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Colon Cancer
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2021-03-15
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blinded placebo-controlled phase 2 study.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Flow-analysis of lymphocytic subpopulations in blood
timeFrame: Change between day of surgery (day 7-14 after first treatment) and postoperative day 1.
measure: T-cell infiltration in tumor
timeFrame: Day of surgery (day 7-14 after first treatment)
Secondary outcomes:
measure: Quality of recovery (QoR-15)
timeFrame: Third postoperative day and postoperative day 12-16
measure: Multiplex gene assay - NanoString Pan Cancer 360 IO panel analysis in blood and resected tumor
timeFrame: Day of first treatment (Day 0) and day of surgery (day 7-14 after first treatment)
measure: cfDNA analysis in blood
timeFrame: 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.
measure: Multiplex gene assay - NanoString Pan Cancer 360 IO panel analysis of tumor biopsy and resected specimen
timeFrame: Day of standard endoscopic biopsy (Day -7-14 before treatment) and day of surgery (day 7-14 after first treatment)
measure: CRP and neutrophil/lymphocyte ratio
timeFrame: Day of surgery (day 7-14 after first treatment)
measure: Immunological and inflammatory cytokines and interleukins
timeFrame: Day of surgery (day 7-14 after first treatment) and postoperative day 1.
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev University Hospital
state: Zealand
Study officials:
References: