Colon CancerPhase 2IPOSNCT04798612
Effect of Low-dose Interferon-alfa2a on Peri-operative Immune Suppression
A Phase 2 study testing Pegasys and Saline in people with Colon Cancer, run by Zealand University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Pegasys and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteDenmark
- Study dates
- 14 Aug 2023to 1 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Herlev University Hospital
Herlev, Region Sjælland, 2730
Helin Yikilmaz Pardes, MD, 28913473 ext. 0045, heyi@regionsjaelland.dk
Ismail Gögenur, MD, Professor
About this study
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
- Being tested
- Pegasys, Saline
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegasysDrug
45 mikrograms of Pegasys. Two subcutanous doses will be administered with at least 7 days in between
SalineDrug
0.50 ml of Saline. Two subcutanous doses will be administered with at least 7 days in between
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-analysis of lymphocytic subpopulations in blood
Change in CD3, CD4, and CD8 between intervention and placebo groups
Measured: 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
Measured: Day of surgery (day 7-14 after first treatment)
Secondary outcomes (6)
Quality of recovery (QoR-15)
Difference in QoR-15 between intervention and placebo groups
Measured: Third postoperative day and postoperative day 12-16
Multiplex gene assay - NanoString Pan Cancer 360 IO panel analysis in blood and resected tumor
Difference in gene expressions between intervention and placebo groups
Measured: 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
Measured: 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
Measured: 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
Measured: Day of surgery (day 7-14 after first treatment)
Immunological and inflammatory cytokines and interleukins
Difference between intervention and placebo groups
Measured: Day of surgery (day 7-14 after first treatment) and postoperative day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start14 Aug 2023
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded placebo-controlled phase 2 study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798612
- Sponsor's protocol ID
- SJ-874
- Acronym
- IPOS
- Status last verified
- Aug 2023
- First submitted
- 9 Mar 2021
- Last updated
- 18 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-dose Interferon-alfa2a on Peri-operative Immune Suppression
- ClinicalTrials.gov ID
- NCT04798612
- Acronym / sponsor ID
- IPOS / SJ-874
- Conditions
- Colon Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-blinded placebo-controlled phase 2 study.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Drug: PegasysTwo 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 | Drug: SalineTwo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pegasys45 mikrograms of Pegasys. Two subcutanous doses will be administered with at least 7 days in between | Drug | Intervention arm |
| Saline0.50 ml of Saline. Two subcutanous doses will be administered with at least 7 days in between | Drug | Placebo |
Primary outcome
Flow-analysis of lymphocytic subpopulations in blood
Time frame: 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
Time frame: Day of surgery (day 7-14 after first treatment)
Difference in CD3, CD4 and CD8 T-cell infiltration between intervention and placebo groups
6 secondary outcomes
Quality of recovery (QoR-15)
Time frame: Third postoperative day and postoperative day 12-16
Multiplex gene assay - NanoString Pan Cancer 360 IO panel analysis in blood and resected tumor
Time frame: Day of first treatment (Day 0) and day of surgery (day 7-14 after first treatment)
cfDNA analysis in blood
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.
Multiplex gene assay - NanoString Pan Cancer 360 IO panel analysis of tumor biopsy and resected specimen
Time frame: 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
Time frame: Day of surgery (day 7-14 after first treatment)
Immunological and inflammatory cytokines and interleukins
Time frame: Day of surgery (day 7-14 after first treatment) and postoperative day 1.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pegasys and Saline in people with Colon Cancer, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ismail Gögenur, MD, Professor (26356426 ext. 0045, igo@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow-analysis of lymphocytic subpopulations in blood (time frame: Change between day of surgery (day 7-14 after first treatment) and postoperative day 1.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2023.