Study on the Effectiveness and Safety of VS-101 with Chemoradiotherapy for Head and Neck Cancer

Inclusion Criteria

• Adults over 18 years old.
• Diagnosed with head and neck squamous cell carcinoma in areas like the oral cavity, oropharynx, hypopharynx, or larynx, confirmed by imaging tests and pathology.
• Cancer stages as defined by specific guidelines, including Stage III, IVa, or IVb for certain types.
• Have measurable cancer based on specific criteria.
• Receiving standard radiation therapy without surgery.
• Prescribed a specific type of radiation therapy with a planned dose of 70 Gy.
• Have a performance status score of 0 to 2, indicating good overall health.
• Have mild or no adverse reactions at the time of screening.
• Expected to live at least 20 weeks.
• Able to follow the study requirements.
• Understand and agree to sign a consent form.

Exclusion Criteria

• History of radiation to the head and neck or conditions that make radiation unsafe.
• Mental health issues like major depression or suicidal behavior.
• Certain medical conditions like uncontrolled diabetes or heart problems.
• History of seizures or conditions affecting cognitive and motor skills.
• Conditions that increase body temperature or cause swallowing difficulties.
• Significant allergies or drug sensitivities.
• Abnormal lab test results, such as high liver enzymes or low blood counts.
• Positive tests for certain infections like hepatitis or HIV.
• Recent use of certain medications or participation in other clinical trials.
• Not using effective birth control if of childbearing potential.
• Any other reason deemed unsuitable by the study investigators.