Actively Recruiting
Efficacy and Safety Evaluation of VS-101 in Combination With Chemoradiotherapy in Patients With Head and Neck Cancer
Led by VSPharmTech Co.,Ltd. · Updated on 2026-03-11
30
Participants Needed
3
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This will be a multi-center, randomized, open-label, parallel-group study in adult patients with head and neck cancer.
CONDITIONS
Official Title
Efficacy and Safety Evaluation of VS-101 in Combination With Chemoradiotherapy in Patients With Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged more than 18 years at the time of informed consent
- Diagnosed with head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx confirmed by PET, CT, or MRI and pathology
- Cancer stages defined by AJCC 8th Edition: Stage III, IVa, IVb for oral cavity, hypopharynx, or larynx; Stage III, IVa, IVb for oropharyngeal p16 negative; T4 (N0-N3), M0 or N3 (T1-T4), M0 for oropharyngeal p16 positive
- Measurable disease based on RECIST 1.1
- Receiving definitive chemoradiotherapy without surgical excision
- Prescribed standard intensity-modulated radiation therapy with daily 2.0 Gy fractions to a total dose of 70 Gy
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- National Cancer Institute-Common Terminology Criteria for Adverse Events Grade 1 or lower for acute or chronic adverse reactions at screening
- Expected survival of at least 20 weeks
- Ability to comply with study protocol requirements
- Willingness and ability to sign informed consent
You will not qualify if you...
- History of prior radiation to the head and neck or known radiation susceptibility
- History of suicidal behavior, major depression, or psychiatric disorders including bipolar disorder and ADHD
- Neuroleptic malignant syndrome, tardive dyskinesia, dementia in elderly, uncontrolled diabetes or hyperglycemia, venous thromboembolism
- Orthostatic hypotension due to cardiovascular or cerebrovascular disease or prone conditions
- History of seizures
- Possible cognitive or motor impairments such as drowsiness or sedation unless deemed not impairing by investigator
- Conditions increasing core body temperature, such as strenuous exercise or dehydration
- Dysphagia or related conditions unless deemed unlikely by investigator
- History of significant allergic diseases or hypersensitivity to drugs except mild allergic rhinitis
- Abnormal lab results including elevated liver enzymes, low creatinine clearance, low blood counts, abnormal calcium or bilirubin, coagulation abnormalities
- Positive tests for hepatitis B or C, HIV, or syphilis
- Significant ECG abnormalities such as prolonged QTcF
- Prior hypofractionated chemoradiation (>2 Gy per day)
- Hypersensitivity to study drug components
- History of drug abuse especially hypnotics, analgesics, opiates, or CNS drugs
- Use of CYP3A4 or CYP2D6 inducers/inhibitors within 28 days
- Chemotherapy within 28 days prior to baseline
- Recent use of intravenous antibiotics, antivirals, or antifungals within 14 days
- Use of benzodiazepines within 3 days prior to baseline
- Participation in another clinical trial within 4 weeks prior to baseline
- Not using medically acceptable contraception during and after treatment as specified
- Judged unsuitable for study participation by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Yale Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
2
Cancer Center of Kansas
Wichita, Kansas, United States, 67214
Actively Recruiting
3
NYU Langone Health
Manhattan, New York, United States, 10016
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here