A Multi-center, Randomized, Open-label, Parallel-group, Phase 2 Study to Evaluate the Efficacy and Safety of VS-101 in Combination With Chemoradiotherapy (CRT) in Patients With Head and Neck Cancer
VSPharmTech Co.,Ltd.
Summary
This will be a multi-center, randomized, open-label, parallel-group study in adult patients with head and neck cancer.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Males or females aged more than 18 years at the time of ICF signing 2. Diagnosed based on position emission tomography (PET), computed tomography (CT), or magnetic resonance imaging (MRI) with pathologically confirmed (histologic or cytological) head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx 3. Defined by American Joint Committee on Cancer \[AJCC\] Guidelines 8th Edition: * Oral cavity, hypopharynx, or larynx (independent of p16): Stage III, IVa, IVb per TNM guidelines; or * Oropharyngeal p16 negative disease: Stage I…
Interventions
- DrugVS-101
VS-101
- DrugCisplatin
Cisplatin
- RadiationRadiation
Radiation
Locations (3)
- Yale Cancer CenterNew Haven, Connecticut
- Cancer Center of KansasWichita, Kansas
- NYU Langone HealthManhattan, New York