Intratumoral Influenza Vaccine for Early Colorectal Cancer

Phase 1

• Conditions: Patients with colorectal cancer; MedDRA version: 21.0Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: PTClassification code 10010032Term: Colorectal cancer stage ISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: PTClassification code 10010033Term: Colorectal cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: PTClassification code 10010034Term: Colorectal cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2020-000725-27-DK
• Lead Sponsor: Center for Surgical Science, Department of Surgery, Zealand University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-24
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified