Study on Preserving Voice Box Function in Patients with Recurrent or Metastatic Head and Neck Cancer
Sponsor: Matthew Spector
ClinicalTrials ID:NCT07423078
This clinical trial is exploring a treatment approach using chemotherapy and immunotherapy to help preserve the voice box function in adults with recurrent or metastatic head and neck cancer. The study aims to assess the safety and effectiveness of this treatment in improving survival rates.
Patient Parameters
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Program Overview
The trial is investigating whether a combination of chemotherapy drugs (carboplatin or cisplatin, and paclitaxel) with an immunotherapy drug (toripalimab) can safely and effectively treat patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The goal is to see if this treatment can help preserve the function of the larynx (voice box) and improve survival rates in patients who might otherwise need surgery that removes the larynx.
Description
For patients with advanced laryngeal or hypopharyngeal squamous cell carcinoma, the usual treatment options include surgery to remove the larynx (voice box) followed by additional therapy, or trying to preserve the larynx with other treatments. Removing the larynx is a major surgery that results in the patient breathing through a hole in the neck permanently. Recently, there has been concern that this surgery might reduce survival rates in patients with very advanced cancer. This study is testing a new approach that uses chemotherapy and immunotherapy before any surgery to see if it can help select patients who might benefit from treatments that preserve the larynx. The immunotherapy drug toripalimab, when combined with chemotherapy, has shown promise in improving survival in other types of cancer. The hope is that this combination can improve the response to treatment, reduce the need for larynx removal, and improve survival in patients with this serious disease.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with squamous cell carcinoma of the larynx or hypopharynx that has not been treated before.
- Cancer is at Stage III or IV and can potentially be removed with surgery.
- Good overall health with a performance status score between 0 and 2.
- Willing to use effective birth control during the study and for one year after treatment.
- Women must not be pregnant or breastfeeding and must meet specific criteria if of childbearing potential.
- Normal organ and bone marrow function as shown by specific blood tests.
- Able to understand and sign a consent form to participate in the study.
Exclusion Criteria
- Previous treatment for head and neck cancer.
- Cancer that cannot be surgically removed.
- Cancer that has spread to distant parts of the body.
- Active autoimmune disease requiring treatment or certain lung conditions.
- Allergies to the study drugs.
- Recent history of another cancer that could affect the study results.
- Severe nerve damage.
- Conditions or treatments that could interfere with the study.
- Active hepatitis B or C, or untreated HIV infection, unless specific criteria are met.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UPMC Hillman Cancer | 15213 | Pittsburgh | Pennsylvania |
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