Clinical trial · Observational
Immune Response Evaluation to Curative Conventional Therapy
Immune Response Evaluation to Curative Conventional Therapy of Stage III/IV Head and Neck Squamous Cell Carcinoma Patients
- 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 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.
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 |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- primary surgery + adj. C)RT
- description
- treatment naive patients to be treated by conventional primary surgery followed by adjuvant (chemo-)radiotherapy with curative intent
- label
- primary chemoradiation
- description
- treatment naive patients to be treated by conventional primary chemoradiotherapy with curative intent
Primary outcomes (3)
- measure
- prevalence of spontaneous tumor-specific immunity at baseline
- timeFrame
- baseline
- measure
- dynamics of tumor-specific immunity and immune modulatory cells during conventional treatment
- timeFrame
- 7-12 weeks (treatment phase)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDvon Witzleben A, Fehn A, Grages A, Ezic J, Jeske SS, Puntigam LK, Brunner C, Kraus JM, Kestler HA, Doescher J, Brand M, Theodoraki MN, Ottensmeier CH, Hoffmann TK, Schuler PJ, Laban S. Prospective longitudinal study of immune checkpoint molecule (ICM) expression in immune cell subsets during curative conventional therapy of head and neck squamous cell carcinoma (HNSCC). Int J Cancer. 2021 Apr 15;148(8):2023-2035. doi: 10.1002/ijc.33446. Epub 2020 Dec 30. PMID 33336372