Immune Response Evaluation to Curative Conventional Therapy of Stage III/IV Head and Neck Squamous Cell Carcinoma Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 22
- Primary Endpoint
- prevalence of spontaneous tumor-specific immunity at baseline
Study Overview
Brief Summary
The IRECT trial is a non-interventional, prospective clinical trial using modern immune monitoring techniques over the course of the standard of care for HNSCC. The dynamics of host/tumor immune interactions during the conventional standard treatment will be analyzed to find the most promising target antigen and to develop a strategy how and when specific immunotherapy should be added to the current treatment schedule.
The results from this trial will help to understand how state of the art treatment can be complemented using cancer-testis antigen specific vaccines and immune-modulating drugs to improve the outcome of head and neck cancer patients.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •newly diagnosed patients with stage III-IVa/b head and neck squamous cell carcinoma
- •fit for treatment with curative intent
- •conventional primary treatment
- •primary surgical treatment
- •primary radiotherapeutic treatment
- •informed consent
- •>18 years of age
- •sufficient contraception
Exclusion Criteria
- •distant metastasis at baseline
- •severe concomitant disease compromising curative treatment
- •previously diagnosed other malignant diseases
- •active immunosuppressive therapy
- •known immune defect
- •pregnancy
- •anemia requiring treatment at study entry (<9g/dl)
Outcomes
Primary Outcomes
prevalence of spontaneous tumor-specific immunity at baseline
Time Frame: baseline
dynamics of tumor-specific immunity and immune modulatory cells during conventional treatment
Time Frame: 7-12 weeks (treatment phase)
dynamics of tumor-specific immunity and immune modulatory cells during follow up
Time Frame: 12 months after end of treatment
Secondary Outcomes
- progression free survival at 3 years(baseline - 3 years)
- overall survival at 3 years(baseline - 3 years)
Investigators
Simon Laban, MD
Head & Neck Cancer Lead, Interdisciplinary Oncologic Outpatient Unit
University of Ulm