E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with colorectal cancer |
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E.1.1.1 | Medical condition in easily understood language |
Patients with colorectal cancer |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061451 |
E.1.2 | Term | Colorectal cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10010032 |
E.1.2 | Term | Colorectal cancer stage I |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10010033 |
E.1.2 | Term | Colorectal cancer stage II |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10010034 |
E.1.2 | Term | Colorectal cancer stage III |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Before treatment with influenza vaccine and before surgery. |
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E.5.2 | 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). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Before treatment with influenza vaccine, before surgery, postoperative day 2-3 and postoperative day 12-16 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |