Colon Cancer
Conditions
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.
Interventions
DRUGPegasys
45 mikrograms of Pegasys. Two subcutanous doses will be administered with at least 7 days in between
DRUGSaline
0.50 ml of Saline. Two subcutanous doses will be administered with at least 7 days in between
Sponsors
University of Copenhagen
Zealand University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Double-blinded placebo-controlled phase 2 study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flow-analysis of lymphocytic subpopulations in blood | Change between day of surgery (day 7-14 after first treatment) and postoperative day 1. | Change in CD3, CD4, and CD8 between intervention and placebo groups |
| T-cell infiltration in tumor | Day of surgery (day 7-14 after first treatment) | Difference in CD3, CD4 and CD8 T-cell infiltration between intervention and placebo groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Difference between intervention and placebo groups |
| 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) | Difference in gene expressions in tumor biopsies and resected specimen between intervention and placebo groups |
| Quality of recovery (QoR-15) | Third postoperative day and postoperative day 12-16 | Difference in QoR-15 between intervention and placebo groups |
| Immunological and inflammatory cytokines and interleukins | Day of surgery (day 7-14 after first treatment) and postoperative day 1. | Difference between intervention and placebo groups |
| CRP and neutrophil/lymphocyte ratio | Day of surgery (day 7-14 after first treatment) | Difference in CRP and neutrophil/lymphocyte ratio between intervention and placebo groups |
| 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) | Difference in gene expressions between intervention and placebo groups |
Countries
Denmark
Contacts
Primary ContactIsmail Gögenur, MD, Professor
Backup ContactHelin Yikilmaz Pardes, MD
Outcome results
None listed