Intratumoral Influenza Vaccine for Early Colorectal Cancer

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this explorative phase II clinical trial is to establish the safety and efficacy of intratumoral influenza vaccine in patients with colorectal cancer, as an additive treatment prior to intended curative surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zealand University Hospital
• Collaborator: University of Copenhagen

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.

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