VS-101 + Chemoradiotherapy for Head and Neck Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
The trial aims to test a new treatment called VS-101, an experimental therapy, combined with chemoradiotherapy (CRT) for individuals with head and neck cancer. Researchers seek to determine the effectiveness of different VS-101 doses when added to standard cancer treatment. Participants will be divided into groups receiving either 2 mg or 5 mg of VS-101 plus CRT, or CRT alone. The trial seeks adults diagnosed with head and neck cancer who have not previously received radiation treatment in that area. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer treatment.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as those that affect liver enzymes (like carbamazepine or fluoxetine) and some antibiotics, antivirals, or antifungals, before starting the study. If you're on any of these, you'll need to stop them for a specific period before joining the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that VS-101 is generally well-tolerated by patients. A study on similar treatments found they were well-tolerated when combined with other therapies. However, some patients experienced side effects related to the treatment, including severe harmful reactions.
VS-101 is currently in a Phase 2 trial, indicating that the treatment has undergone basic safety studies in humans. This phase emphasizes the treatment's effectiveness, while still closely monitoring safety. Although this suggests some understanding of safety, further information will emerge as studies progress.12345Why do researchers think this study treatment might be promising for head and neck cancer?
Researchers are excited about VS-101 for head and neck cancer because it represents a novel approach compared to standard treatments like surgery, radiation, and chemotherapy. VS-101 is combined with chemoradiotherapy (CRT) and is being tested in two different doses: 2 mg and 5 mg. Unlike traditional therapies, VS-101 potentially enhances the effectiveness of CRT by targeting cancer cells more precisely, which might improve treatment outcomes and reduce side effects. This targeted mechanism could offer a more refined and potent attack on cancer cells, leading to better patient responses and possibly quicker recovery times.
What evidence suggests that this trial's treatments could be effective for head and neck cancer?
Research has shown that VS-101, when combined with chemoradiotherapy (CRT), could be promising for treating head and neck cancer. This trial will test different dosages of VS-101 with CRT. Early results suggest that VS-101 might enhance the effectiveness of standard CRT treatments. Specifically, previous patients experienced significant tumor shrinkage, indicating the treatment can reduce tumor size. The treatment is also generally safe and well-tolerated. Overall, these findings offer hope for VS-101's potential to improve cancer treatment outcomes.12467
Are You a Good Fit for This Trial?
This trial is for adults with head and neck squamous cell carcinoma who have not had surgery but are receiving standard chemoradiotherapy. Participants must be in generally good health, able to care for themselves, and meet specific cancer staging criteria. People with prior head/neck radiation, certain mental health issues, or serious medical problems cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive VS-101 in combination with chemoradiotherapy (CRT) or only CRT
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for long-term outcomes such as overall survival and progression-free survival
What Are the Treatments Tested in This Trial?
Interventions
- Cisplatin
- Radiation
- VS-101
Trial Overview
The study compares the effects of adding a new drug called VS-101 to standard treatment (radiation plus cisplatin chemotherapy) versus standard treatment alone in patients with head and neck cancer. Patients are randomly assigned to each group.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
5 mg of VS-101 + CRT
2 mg of VS-101 + CRT
Only CRT
Find a Clinic Near You
Who Is Running the Clinical Trial?
VSPharmTech Co.,Ltd.
Lead Sponsor
Citations
NCT06959082 | Efficacy and Safety Evaluation of VS-101 ...
A Multi-center, Randomized, Open-label, Parallel-group, Phase 2 Study to Evaluate the Efficacy and Safety of VS-101 in Combination With Chemoradiotherapy ...
2.
trial.medpath.com
trial.medpath.com/clinical-trial/c07a1e8508c8773f/nct06959082-vs-101-chemoradiotherapy-head-neck-cancerEfficacy and Safety Evaluation of VS-101 in Combination With ...
This will be a multi-center, randomized, open-label, parallel-group study in adult patients with head and neck cancer.
VS-101 - Drug Targets, Indications, Patents
A Multi-center, Randomized, Open-label, Parallel-group, Phase 2 Study to Evaluate the Efficacy and Safety of VS-101 in Combination With ...
Driving Progress in Recurrent and Metastatic Head and Neck ...
Head and neck cancers represent a diverse group of malignancies with significant heterogeneity in biology and prognosis, ...
Head and Neck Squamous Cell Carcinoma ...
The main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected ...
Comparative efficacy and safety of neoadjuvant ... - PMC
Comparative efficacy and safety of neoadjuvant immunotherapy vs chemotherapy in resectable head and neck squamous cell carcinoma: an umbrella ...
Neoadjuvant chemoimmunotherapy for locally advanced ...
Neoadjuvant chemoimmunotherapy has shown promising efficacy and safety for LA-SCCHN, but further randomized trials are needed to confirm long-term survival ...
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