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VS-101 with Chemoradiotherapy for Head and Neck Cancer

This study is testing a new drug called VS-101 in combination with standard treatments (Cisplatin chemotherapy and radiation) for people with head and neck squamous cell carcinoma. Researchers want to see how well this combination works to shrink tumors. You might be able to join if you are over 18 and have been diagnosed with head and neck squamous cell carcinoma in areas like the mouth, throat, or voice box. The study will look at how many patients respond to the treatment after 6 and 12 months. The current status of this study is unclear, but it plans to enroll about 30 participants.

Study design
This is a multi-center, randomized, open-label study, meaning some participants will receive the new drug and others won't, and everyone will know which treatment they are getting. It plans to enroll about 30 adult patients.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how well the treatment works at 6 and 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06959082

Efficacy and Safety Evaluation of VS-101 in Combination With Chemoradiotherapy in Patients With Head and Neck Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
VSPharmTech Co.,Ltd.
~30 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:VS-101CisplatinRadiation

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective response rate (ORR)
Measured over 6 months and 12 months

Conditions

Head and Neck Cancer Squamous Cell Carcinoma

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Head and Neck Squamous Cell Carcinoma

Where it's being run

2 sites across 2 states
Connecticut1
New York1

Who to contact

Clinical Research Coordinator
[email protected]
203-228-2385
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Oral cavity, hypopharynx, or larynx (independent of p16): Stage III, IVa, IVb per TNM guidelines; or
Oropharyngeal p16 negative disease: Stage III, IVa, IVb per TNM guidelines; or
Oropharyngeal p16 positive disease: Stage III per TNM guidelines 4. Have measurable disease based on RECIST 1.1 5. Participants with head and neck cancer who have limited to those receiving definitive CRT without surgical excision 6. Participants prescribed standard intensity-modulated radiation therapy (IMRT) with a cumulative planned dose of approximately 70 Gy 7. Participants with Eastern Cooperative Oncology Group (ECOG) Performance Statue (PS) of 0 \~ 2 8. Participants with the status of National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) version 6.0 Grade 2 if stable and not clinically significant, or lower for acute or chronic adverse reaction at the time of screening 9. Participants with an expected survival period of at least 20 weeks 10. Participants who can comply with the requirements of the clinical trial protocol 11. Ability to understand and willingness to sign a written informed consent document

What this trial measures

  • Objective response rate (ORR)6 months and 12 months

    The proportion of participants who achieve an ORR at 6 months and 12 months will be summarized with the 95% confidence interval on the mITT and PP samples.