Efficacy and Safety Evaluation of VS-101 in Combination With Chemoradiotherapy in Patients With Head and Neck Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVSPharmTech Co.,Ltd.
About this trial
This will be a multi-center, randomized, open-label, parallel-group study in adult patients with head and neck cancer.
Eligibility criteria
Qualifiers
Males or females aged more than 18 years at the time of ICF signing
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
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
Disqualifiers
Medical History
Patients with a history of prior radiation to the head and neck region which overlap with the planned radiation fields (or cumulative doses exceed the constraints for organs-at-risk [OAR]) or with a known susceptibility to radiation.
Patients with active or uncontrolled or clinically significant medical or psychiatric disorders that, in the investigator's opinion, may interfere with informed consent, adherence, or patient safety. Stable medical or psychiatric conditions under a stable dose regimen are permitted.
Patients with a history of uncontrolled seizure disorder. Patients with a remote history of a single provoked seizure or well-controlled seizures on stable monotherapy may be eligible.
Trial design
Treatments tested in this trial
- VS-101
- Cisplatin
- Radiation
Treatment groups
30 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov