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

ConditionHead and Neck Cancer Squamous Cell Carcinoma
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • VS-101

    Drug

    VS-101

  • Cisplatin

    Drug

    Cisplatin

  • Radiation

    Radiation

    Radiation

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: 2 mg of VS-101 + CRTExperimental treatment 3 interventions
Group B: 5 mg of VS-101 + CRTExperimental treatment 3 interventions
Group C: Only CRTPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

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.

Time frame
6 months and 12 months

Secondary outcomes

1

Disease control rate (DCR)

proportion of subjects who have a complete response (CR), partial response (PR), or stable disease (SD) at 6 months and 12 months will be summarized with the 95% confidence interval on the mITT and PP samples.

Time frame
6 months and 12 months
2

Best overall response (BOR)

The BOR will be based on all post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy. BOR will be summarized for the following categories: CR, PR, SD, PD and non-evaluable.

Time frame
6 months and 12 months
3

Progression-free survival (PFS)

The PFS will be analyzed using Kaplan-Meier methods on the mITT and PP samples. KM estimates and associated two-sided 95% confidence intervals will be presented for each cohort. Participants who have no documented progression and are still alive at the time of analysis will be censored at the time of the latest date of assessment.

Time frame
At 6 month and 1 year
4

Locoregional control (LRC)

Rate of Locoregional recurrence after end of treatment (FDG-PET/CT scan).

Time frame
At 6 month and 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VSPharmTech Co.,Ltd.

Lead sponsor

Source ClinicalTrials.gov
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