Peginterferon alfa-2a for Colon cancer|Colonic adenocarcinoma (pMMR)

Inclusion criteria

• {"criterion_text":"- 1. Patients above 18 years of age."}
• {"criterion_text":"- 2. Patients diagnosed with pMMR colonic adenocarcinoma and scheduled for laparoscopic hemicolectomy."}
• {"criterion_text":"- 3. ASA class I-III (Classification of the American Society of Anesthesiology)"}

Exclusion criteria

• {"criterion_text":"- •\tPatients with childbearing potential without a negative pregnancy test before initiating study drug and / or non-acceptance to the use of contraceptive methods *"}
• {"criterion_text":"- •\tECOG score function> / = 3"}
• {"criterion_text":"- •\tCurrent liver or renal disease."}
• {"criterion_text":"- •\tSevere heart disease"}
• {"criterion_text":"- •\tPrevious depression diagnosed by a psychiatrist or in treatment with antidepressant"}
• {"criterion_text":"- •\tAutoimmune disease."}
• {"criterion_text":"- •\tUncontrolled thyroid disease."}
• {"criterion_text":"- •\tPatients who are or have recently (within 6 months) received treatment with immunosuppressive agents other than corticosteroid treatment."}
• {"criterion_text":"- •\tEpilepsy and / or other serious CNS disorders."}
• {"criterion_text":"- •\tPatients that have undergone major surgery within one month before planned colon resection."}
• {"criterion_text":"- •\tKnown hypersensitivity to recombinant interferon or auxiliary products of Pegasys®."}
• {"criterion_text":"- * Spiral, pill, implant, transdermal patch, vaginal ring or depot injection. Sterile / infertile\tsubjects are exempt from the use of contraception. To be considered sterile or infertile must\tgenerally be surgical sterilization (vasectomy, bilateral tubectomy, hysterectomy or\tovariectomy) or be postmenopausal, defined as absent menstruation for at least 12 months prior to study enrolment."}

Primary endpoints

• {"endpoint_text":"- •\tDifferences in measures of lymphocytic subpopulations (FLOW) between intervention and placebo group, seen as a higher number of CD3, 4, 8 and HLA-positive cells in the intervention group, on the day of and the day after surgery.","definition_or_measurement_approach":"Measured by flow cytometry (FLOW) assessing numbers of CD3, CD4, CD8 and HLA-positive cells on the day of and the day after surgery."}
• {"endpoint_text":"- •\tDifferences in tumor-infiltrating lymphocytes in the resected specimen at the tumor center and invasive margin between the intervention and placebo group. This will be analysed via immunohistochemistry with staining for CD3+, CD4+ and CD8+ T-cells.","definition_or_measurement_approach":"Analysed via immunohistochemistry with staining for CD3+, CD4+ and CD8+ T-cells in resected specimen at tumour centre and invasive margin."}

Secondary endpoints

• {"endpoint_text":"- A few of them: 1)Differences in measures of Quality of recovery (QoR-15) between intervention and placebo group, seen as a higher mean QoR in intervention group on the third and 12-16 post-operative day.","definition_or_measurement_approach":"Measured using QoR-15 score on postoperative day 3 and days 12-16."}
• {"endpoint_text":"- 2) Differences in phenotype and clonality of tumor-infiltrating and circulating T cells between placebo and intervention group, analyzed via combined single-cell transcriptome and TCR sequencing.","definition_or_measurement_approach":"Analysed via combined single-cell transcriptome and TCR sequencing to assess phenotype and clonality of tumour-infiltrating and circulating T cells."}
• {"endpoint_text":"- 3) Differences in tumor microenvironment in the resected specimen.","definition_or_measurement_approach":"Tumor microenvironment analysis (detailed methods not specified here; elsewhere multiplex gene assay is referenced)."}

Other endpoints

• {"endpoint_text":"- •\tDifferences in measures of Quality of recovery (QoR-15) between intervention and placebo group, seen as a higher mean QoR in intervention group on the third and 12-16 post-operative day.","definition_or_measurement_approach":"Measured using QoR-15 score on postoperative day 3 and days 12-16."}
• {"endpoint_text":"- •\tDifferences in key systemic immune responses in blood, between the intervention and placebo group on samples taken before first treatment and before surgery, analysed via a multiplex gene assay. The multiplex gene assays include pathways related to antigen presentation (MHC-I, MHC-II, CD3, CD4 and CD8 related pathways) and related to innate cytotoxic and inflammatory activity (NK cells, macrophages and neutrophils).","definition_or_measurement_approach":"Analysed via multiplex gene assay on blood samples taken before first treatment and before surgery, assessing antigen-presentation and innate cytotoxic/inflammatory pathways."}
• {"endpoint_text":"- •\tDifferences in tumor microenvironment in the resected specimen, analysed via a multiplex gene assay, between the placebo and intervention group. The multiplex gene assays include pathways related to antigen presentation (MHC-I, MHC-II, CD3, CD4 and CD8 related pathways) and related to innate cytotoxic and inflammatory activity (NK cells, macrophages and neutrophils).","definition_or_measurement_approach":"Analysed via multiplex gene assay examining antigen-presentation and innate cytotoxic/inflammatory pathways in resected tumour specimens."}
• {"endpoint_text":"- •\tDifferences in cfDNA on approximately day 7 and day 1 before surgery and day 2, 12-16 and 28-32 after surgery between the placebo and intervention group.","definition_or_measurement_approach":"Cell-free DNA (cfDNA) measured at specified perioperative timepoints (approx. day -1 and day 7 before surgery; day 2, days 12-16 and days 28-32 after surgery)."}
• {"endpoint_text":"- •\tIntragroup differences in tumor microenvironment in the biopsy before surgery vs the resected specimen.","definition_or_measurement_approach":"Comparison of tumour microenvironment between pre-surgery biopsy and resected specimen (methodology referenced elsewhere as multiplex assays)."}
• {"endpoint_text":"- •\tDifferences in measures of standard blood samples between the two groups, seen as a lower inflammation-grade in the intervention group, on the day prior to surgery (lower CRP and neutrophil/leukocyte ratio).","definition_or_measurement_approach":"Standard blood tests including CRP and neutrophil/leukocyte ratio measured on day prior to surgery."}
• {"endpoint_text":"- •\tDifferences in cytokines and interleukins related to post-operative inflammation between placebo and intervention group, with lower measures of inflammatory cytokines on the day before and the day after surgery in the intervention group.","definition_or_measurement_approach":"Cytokine and interleukin assays measured on the day before and the day after surgery."}
• {"endpoint_text":"- •\tDifferences in phenotype and clonality of tumor-infiltrating and circulating T cells between placebo and intervention group, analyzed via combined single-cell transcriptome and TCR sequencing.","definition_or_measurement_approach":"Analysed via combined single-cell transcriptome and TCR sequencing."}

Denmark

Earliest CTIS Part Ii Submission Date

23-09-2024

Latest Decision Or Authorization Date

20-01-2026

Processing Time Days

484

Number Of Sites

2

Number Of Participants

68

Primary sponsor

Full Name

Region Sjaelland

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}