Immune biomarker testing in cisplatin-ineligible head and neck squamous cell cancer patients treated with chemoradiation and docetaxel

Immune Biomarker Study for Cisplatin-ineligible Patients Receiving Chemoradiotherapy With Docetaxel

This project will test whether immune markers from tumor tissue, blood, saliva and stool can help predict outcomes and show increased tumor immune activity in people with oropharynx, hypopharynx, larynx or oral cavity squamous cell cancer who can't take cisplatin and are receiving chemoradiation with docetaxel.

Quick facts

• Study type: Observational
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Erlangen-Nürnberg Medical School (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Erlangen, Bavaria)
• Trial ID: NCT06947668 on ClinicalTrials.gov

What this trial studies

This observational study analyzes tumor tissue already stored in pathology and collects blood, saliva and stool samples taken during routine care from cisplatin-ineligible patients with squamous cell carcinomas of the oropharynx, hypopharynx, larynx or oral cavity who receive chemoradiation with docetaxel. Laboratory assays will profile immune-related biomarkers in these samples and correlate findings with clinical data on treatment feasibility, tumor control and survival. The study will also look for signs that docetaxel increases tumor immunogenicity. No experimental therapies are given; participation involves sample use and linkage to clinical records.

Who should consider this trial

Good fit: Ideal candidates are patients with squamous cell carcinoma of the oropharynx, hypopharynx, larynx or oral cavity who are planned for definitive or postoperative chemoradiation, are considered unfit for cisplatin by the listed medical criteria, and agree to provide blood, saliva and stool samples.

Not a fit: Patients who can safely receive cisplatin, have non-squamous head and neck cancers, metastatic disease, or who decline sample collection and data use are unlikely to gain direct benefit from this study.

Why it matters

Potential benefit: If successful, the findings could help tailor treatment and follow-up by identifying patients most likely to benefit from docetaxel-based chemoradiation and suggest biomarkers for monitoring.

How similar studies have performed: Biomarker studies and reports of chemotherapy-induced changes in tumor immunity exist in other cancers, but applying biomarker profiling to docetaxel-treated, cisplatin-ineligible head and neck patients is relatively novel and not yet proven.

Eligibility criteria

Inclusion Criteria:

* Patients with squamous cell carcinomas of the oropharynx, larynx and oral cavity for whom definitive or postoperative chemoradiation is indicated
* Patients who are cisplatin-unfit for chemotherapy, defined as:

  * ECOG 2
  * Organ dysfunction ≥ 2 according to National Cancer Institute Common Toxicity Criteria (NCI CTC) Version 4.0, such as hearing loss or tinnitus or neurological diseases
  * Calculated creatinine clearance of ≤50ml/min
  * Impaired organ function or comorbidities that preclude the use of cisplatin, e.g.: left ventricular ejection fraction \< 50%, uncorrectable renal insufficiency with elevated creatinine despite creatinine clearance of 50ml/min due to increased body weight, uncontrolled hypertension
  * Poor nutritional status BMI \< 16kg/m²
  * Concomitant use of nephrotoxic drugs that cannot be discontinued or converted due to other illnesses.
  * Willingness of patients to provide blood, saliva and stool samples and consent to the preservation of all samples for study purposes
  * Age ≥ 18 years
  * Sufficient cognitive abilities of the patients to understand the purpose of the study and to consent to it

Exclusion Criteria:

* Distant metastases at the time of diagnosis and simultaneous second cancers, i.e. at the time of study inclusion
* Malignancies in the last 5 years regardless of location (except basal cell carcinoma or cervical uteri)
* Carcinomas in which no sample collection is possible or likely without compromising the pathological assessment
* Persistent drug or medication abuse
* Patients who are unwilling or unable to comply with the protocol and receive treatment
* Patients who are unsuitable for participation in the study due to a language barrier

Where this trial is running

Erlangen, Bavaria

• Universitätsklinikum Erlangen, Strahlenklinik — Erlangen, Bavaria, Germany (RECRUITING)

Study contacts

• Principal investigator: Marlen Haderlein, MD — Universitätsklinikum Erlangen, Strahlenklinik
• Study coordinator: Marlen Haderlein, MD

Conditions: Squamous Cell Carcinoma of Oropharynx, Squamous Cell Carcinoma of the Hypopharynx, Larynx Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma