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

Colon Cancer Clinical Trial

— IPOS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04798612
• Other study ID #: SJ-874
• Status: Recruiting
• Phase: Phase 2
• Start date: August 14, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: August 2023
• Source: Zealand University Hospital
• Contact: Ismail Gögenur, MD, Professor
• Phone: 26356426
• Email: igo[@]regionsjaelland.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: December 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Drug:
• Pegasys
45 mikrograms of Pegasys. Two subcutanous doses will be administered with at least 7 days in between
• Saline
0.50 ml of Saline. Two subcutanous doses will be administered with at least 7 days in between

Locations

Country	Name	City	State
Denmark	Herlev University Hospital	Herlev	Zealand

Sponsors (2)

Lead Sponsor	Collaborator
Zealand University Hospital	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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)
Secondary	Quality of recovery (QoR-15)	Difference in QoR-15 between intervention and placebo groups	Third postoperative day and postoperative day 12-16
Secondary	Multiplex gene assay - NanoString Pan Cancer 360 IO panel analysis in blood and resected tumor	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)
Secondary	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.
Secondary	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)
Secondary	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)
Secondary	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.