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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegasys | Drug | 45 mikrograms of Pegasys. Two subcutanous doses will be administered with at least 7 days in between |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of recovery (QoR-15) | Difference in QoR-15 between intervention and placebo groups | Third postoperative day and postoperative day 12-16 |
| Multiplex gene assay - NanoString Pan Cancer 360 IO panel analysis in blood and resected tumor |
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Inclusion Criteria:
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®.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ismail Gögenur, MD, Professor | Contact | 26356426 | 0045 | igo@regionsjaelland.dk |
| Helin Yikilmaz Pardes, MD | Contact | 28913473 | 0045 | heyi@regionsjaelland.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev University Hospital | Recruiting | Herlev | Region Sjælland | 2730 | Denmark |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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Double-blinded placebo-controlled phase 2 study.
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| Saline | Drug | 0.50 ml of Saline. Two subcutanous doses will be administered with at least 7 days in between |
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Difference in gene expressions between intervention and placebo groups
| Day of first treatment (Day 0) and day of surgery (day 7-14 after first treatment) |
| cfDNA analysis in blood | Difference between intervention and placebo groups | 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 | Difference in gene expressions in tumor biopsies and resected specimen between intervention and placebo groups | 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 | Difference in CRP and neutrophil/lymphocyte ratio between intervention and placebo groups | Day of surgery (day 7-14 after first treatment) |
| Immunological and inflammatory cytokines and interleukins | Difference between intervention and placebo groups | Day of surgery (day 7-14 after first treatment) and postoperative day 1. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D017670 |
| Sodium Compounds |