Colorectal Cancer
Conditions
Brief summary
The primary endpoint will be that 50% or more patients achieve a major pathological response (MPR) that will be defined as < 10 % viable cells corresponding to Mandard tumor regression grade 1-2 (MTRG).
Detailed description
Specific safety outcomes including tumor site perforation and delay of surgery, and changes in the recovery as assessed by the QoR-15 questionnaire, Analysis of tumor samples: Immunohistochemical analysis of CD3+ and CD8+ T cells, spatial protein expression analyses of immune-infiltrated regions of tumors at the different time points, flow cytometry, and full transcriptomic analyses including single cell analysis., Analysis of blood samples: flow cytometry and full transcriptomic analyses including single cell analysis.
Interventions
DRUGInfluvactetra
DRUGinjektionsvæske
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGInfluvac Tetra Saison 2024/2025 Injektionssuspension in einer Fertigspritze Influenza-Impfstoff aus Oberflächenantigen (inaktiviert)
Sponsors
Zealand University Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be that 50% or more patients achieve a major pathological response (MPR) that will be defined as < 10 % viable cells corresponding to Mandard tumor regression grade 1-2 (MTRG). | — |
Secondary
| Measure | Time frame |
|---|---|
| Specific safety outcomes including tumor site perforation and delay of surgery, and changes in the recovery as assessed by the QoR-15 questionnaire, Analysis of tumor samples: Immunohistochemical analysis of CD3+ and CD8+ T cells, spatial protein expression analyses of immune-infiltrated regions of tumors at the different time points, flow cytometry, and full transcriptomic analyses including single cell analysis., Analysis of blood samples: flow cytometry and full transcriptomic analyses including single cell analysis. | — |
Countries
Denmark
Outcome results
None listed