Patients with colorectal cancer MedDRA version: 21.0 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: PT Classification code 10010032 Term: Colorectal cancer stage I System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: PT Classification code 10010033 Term: Colorectal cancer stage I
Conditions
Interventions
Trade Name: Influvactetra
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Influenza vaccine
CAS Number: 8500000-45-5
Current Sponsor code: Influvactetra
Other descriptive name: INFLUE
Sponsors
Center for Surgical Science, Department of Surgery, Zealand University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients must be mentally capable of understanding the information given. • Patients must give written informed consent. • Clinically suspected or histologically verified malignant tumor of the rectum or sigmoid colon. • Tumor described as passable at index endoscopy. • Men or women aged at least 18 years. • Case reviewed by MDT (surgery, radiology, oncology). Case considered curable with standard surgical resection. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: • Highly inflamed gastrointestinal tissue which is ulcerated and bleeding • Ongoing immunosuppressive treatment. • Concurrent treatment with an investigational medicinal product. • Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study recruitments. • Advanced tumor stages, clinical UICC stage IV. • Indication for neoadjuvant chemoradiation or chemotherapy prior to surgery • Acute surgical resection. • Pregnancy • Any previous allergic reaction to influenza vaccine or constituents, egg and chicken proteins, neomycin, formaldehyde or octoxinol-9 • Acute febrile illness • Acute infectious disease • Influenza vaccine administered within 30 days before study inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary: To investigate if intratumoral influenza vaccine is a safe treatment modality for tumor down staging prior to intended curative surgery in patients undergoing treatment for colorectal cancer.;Secondary Objective: Secondary: To investigate if intratumoral influenza vaccine will induce immunologic invassion of the primary tumor. Tertiary: To investigate if the treatment will induce a systemic immunologic response Quality of recovery: To assess quality of recovery for patients recruited into this trial. A quality of recovery questionnaire will be given to patients pre- and post-treatment;Primary end point(s): Safety endpoints Safety evaluation will be performed via continuous assessment of safety parameters by reviewing events as they arise. We will conduct the pilot study in order to measure potential safety issues in a small cohort of patients before including patients in the phase 2 study. The investigation will be put on hold if unacceptable safety issues are detected. Primary safety endpoints: 1. Evaluation of serious adverse events 2. Evaluation of any adverse events reported. ;Timepoint(s) of evaluation of this end point: Before treatment with influenza vaccine and before surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Before treatment with influenza vaccine, before surgery, postoperative day 2-3 and postoperative day 12-16;Secondary end point(s): The efficacy of the treatment will be evaluated according to the pathological examination of the surgical specimen. As such, final tumor staging, tumor regression grade (Mandard classification) T-cell subtype infiltration of the primary tumor and PD1/PDL-1 status before respective to after treatment are considered endpoints parameters. Furthermore, systemic immune responses will be evaluated through a multiplex gene assay, flow cytometry and NK cell activity analysis. A detailed evaluation of patient reported quality of recovery will be performed through repetitive administration of standardized questionnaires before the treatment with influenza vaccine (baseline), before surgery, postoperative day 2-3, and at follow-up (postoperative day 12-16). | — |
Countries
Denmark
Contacts
Public ContactResearch fellow
Center for Surgical Science, Department of Surgery, Zealand University Hospital
Outcome results
None listed