Clinical trial · Observational
Real-world Analysis on the Efficacy and Safety of Neoadjuvant Therapy for Head and Neck Squamous Cell Carcinoma （neoHNSCC）
NCT06011993CI-TRIAL-00069099unknownClinicalTrials.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)
This is a retrospective, single-arm study that assesses the efficacy and safety of neoadjuvant immunotherapy combined with platinum-based chemotherapy for Head and Neck Squamous Cell Carcinoma. This trial will also explore the biomarkers of neoadjuvant immunochemotherapy.
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
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Adverse events
- timeFrame
- 6 months
- description
- Adverse events should be collected, followed up and reported in accordance with prescribed procedures.
Secondary outcomes (2)
- measure
- Major Pathological Response
- timeFrame
- 6 months
- description
- MPR, defined as ≤10% of residual surviving tumors
- measure
- Complete Pathological Response
- timeFrame
- 6 months
- description
- CPR, defined as no residual survivable tumor cells
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-80, male or female； * Cytologically or histologically diagnosed squamous cell carcinoma (except mixed squamous cell carcinoma)； * There was at least one radiographically measurable lesion according to the solid tumor response Evaluation Criteria (RECIST version 1.1)； * Patients with untreated, operable, or potentially resectable head and neck squamous cell carcinoma； Exclusion Criteria: * Malignant diseases other than head and neck squamous cell carcinoma diagnosed within 5 years prior to first administration (excluding basal cell carcinoma of the skin after radical treatment, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection)； * Currently participating in an interventional clinical study or has received another investigational drug or has used investigational devices in the 4 weeks prior to initial dosing； * Evidence of medical history or disease that may interfere with trial results, prevent participants from participating fully in the study, abnormal treatment or laboratory test values, or other conditions that the investigator deems unsuitable for enrollment；
References
Publications (0)
Data not yet available
No reference posted for this study.