Clinical trial · Interventional
Intratumoral Influenza Vaccine for Early Colorectal Cancer
NCT04591379CI-TRIAL-00062653completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Influenza Vaccines | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention arm
- interventionNames
- Drug: Influenza Vaccines
Primary outcomes (1)
- measure
- Safety - Adverse reactions are classified according to CTCAE version 4.0
- timeFrame
- Day of surgery (day 7-14 after treatment)
- description
- 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. Adverse events / reactions are recorded from day of treatment (Day 0) until the surgery, as it will be difficult to differ between adverse events/reactions to the experimental treatment or surgery. All adverse events / reactions should be described in medical terminology in the patient's file and recorded in case report forms (CRF). The following information must be recorded: start date/date when observed, severity, any initiated treatment, assessment of the AE if it meets the criteria for SAE, end date, and relationship to study drug. For AEs that meet the criteria for SAE, the outcome must be recorded.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGogenur M, Balsevicius L, Bulut M, Colak N, Justesen TF, Fiehn AK, Jensen MB, Host-Rasmussen K, Cappelen B, Gaggar S, Tajik A, Zahid JA, Bennedsen ALB, D'Ondes TDB, Raskov H, Saekmose SG, Hansen LB, Salanti A, Brix S, Gogenur I. Neoadjuvant intratumoral influenza vaccine treatment in patients with proficient mismatch repair colorectal cancer leads to increased tumor infiltration of CD8+ T cells and upregulation of PD-L1: a phase 1/2 clinical trial. J Immunother Cancer. 2023 May;11(5):e006774. doi: 10.1136/jitc-2023-006774. PMID 37172969