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

Primary Purpose

Colon Cancer

Status
Recruiting
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Pegasys
Saline
Sponsored by
Zealand University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Herlev University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention arm

Placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

Flow-analysis of lymphocytic subpopulations in blood
Change in CD3, CD4, and CD8 between intervention and placebo groups
T-cell infiltration in tumor
Difference in CD3, CD4 and CD8 T-cell infiltration between intervention and placebo groups

Secondary Outcome Measures

Quality of recovery (QoR-15)
Difference in QoR-15 between intervention and placebo groups
Multiplex gene assay - NanoString Pan Cancer 360 IO panel analysis in blood and resected tumor
Difference in gene expressions between intervention and placebo groups
cfDNA analysis in blood
Difference between intervention and placebo groups
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
CRP and neutrophil/lymphocyte ratio
Difference in CRP and neutrophil/lymphocyte ratio between intervention and placebo groups
Immunological and inflammatory cytokines and interleukins
Difference between intervention and placebo groups

Full Information

First Posted
March 9, 2021
Last Updated
August 14, 2023
Sponsor
Zealand University Hospital
Collaborators
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT04798612
Brief Title
Effect of Low-dose Interferon-alfa2a on Peri-operative Immune Suppression
Acronym
IPOS
Official Title
Effect of Low-dose Interferon-alfa2a on Peri-operative Immune Suppression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 14, 2023 (Actual)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zealand University Hospital
Collaborators
University of Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Double-blinded placebo-controlled phase 2 study.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Pegasys
Intervention Description
45 mikrograms of Pegasys. Two subcutanous doses will be administered with at least 7 days in between
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
0.50 ml of Saline. Two subcutanous doses will be administered with at least 7 days in between
Primary Outcome Measure Information:
Title
Flow-analysis of lymphocytic subpopulations in blood
Description
Change in CD3, CD4, and CD8 between intervention and placebo groups
Time Frame
Change between day of surgery (day 7-14 after first treatment) and postoperative day 1.
Title
T-cell infiltration in tumor
Description
Difference in CD3, CD4 and CD8 T-cell infiltration between intervention and placebo groups
Time Frame
Day of surgery (day 7-14 after first treatment)
Secondary Outcome Measure Information:
Title
Quality of recovery (QoR-15)
Description
Difference in QoR-15 between intervention and placebo groups
Time Frame
Third postoperative day and postoperative day 12-16
Title
Multiplex gene assay - NanoString Pan Cancer 360 IO panel analysis in blood and resected tumor
Description
Difference in gene expressions between intervention and placebo groups
Time Frame
Day of first treatment (Day 0) and day of surgery (day 7-14 after first treatment)
Title
cfDNA analysis in blood
Description
Difference between intervention and placebo groups
Time Frame
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.
Title
Multiplex gene assay - NanoString Pan Cancer 360 IO panel analysis of tumor biopsy and resected specimen
Description
Difference in gene expressions in tumor biopsies and resected specimen between intervention and placebo groups
Time Frame
Day of standard endoscopic biopsy (Day -7-14 before treatment) and day of surgery (day 7-14 after first treatment)
Title
CRP and neutrophil/lymphocyte ratio
Description
Difference in CRP and neutrophil/lymphocyte ratio between intervention and placebo groups
Time Frame
Day of surgery (day 7-14 after first treatment)
Title
Immunological and inflammatory cytokines and interleukins
Description
Difference between intervention and placebo groups
Time Frame
Day of surgery (day 7-14 after first treatment) and postoperative day 1.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ismail Gögenur, MD, Professor
Phone
26356426
Ext
0045
Email
igo@regionsjaelland.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Helin Yikilmaz Pardes, MD
Phone
28913473
Ext
0045
Email
heyi@regionsjaelland.dk
Facility Information:
Facility Name
Herlev University Hospital
City
Herlev
State/Province
Zealand
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helin Yikilmaz Pardes, MD
Phone
28913473
Ext
0045
Email
heyi@regionsjaelland.dk
First Name & Middle Initial & Last Name & Degree
Ismail Gögenur, MD, Professor
First Name & Middle Initial & Last Name & Degree
Helin Yikilmaz Pardes, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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