Study on Toripalimab and Chemotherapy for Treating Sinus Cancer
Sponsor: Glenn J. Hanna
ClinicalTrials ID:NCT06940180
This clinical trial is testing a new treatment that combines the immunotherapy drug toripalimab with chemotherapy drugs carboplatin and docetaxel to see if it is safe and effective for patients with sinus cancer before surgery.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate the safety and effectiveness of a new treatment for sinonasal cancers, which are cancers in the nasal cavity and sinuses. The treatment combines an immunotherapy drug called toripalimab with chemotherapy drugs carboplatin and docetaxel. Toripalimab works by helping the immune system attack cancer cells. Although toripalimab is not yet approved for sinonasal cancers, it is approved for another type of head and neck cancer. The study involves various tests and procedures, including blood tests, scans, and tumor imaging, to monitor the treatment's effects. About 20 people are expected to participate in this study, which is funded by Coherus Biosciences.
Description
This study is designed to test a new treatment approach for sinonasal cancers, which are cancers located in the nasal cavity and sinuses. The treatment involves using an immunotherapy drug called toripalimab along with chemotherapy drugs carboplatin and docetaxel before surgery. Toripalimab helps the immune system recognize and fight cancer cells by blocking certain proteins that allow cancer cells to hide from the immune system. While toripalimab is not yet approved for sinonasal cancers, it is approved for treating another type of head and neck cancer. The study will include various procedures such as blood tests, scans, and imaging to assess the treatment's safety and effectiveness. Approximately 20 participants will be involved in this study, which is supported by Coherus Biosciences.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of advanced nasal cavity or sinus cancer, specifically certain types like squamous cell carcinoma or sinonasal undifferentiated carcinoma.
- Cancer must be operable or borderline operable, meaning it can be removed with surgery, although it may require extensive surgery.
- Must have a specific stage of cancer as defined by medical guidelines.
- Must be willing to provide blood and tissue samples for analysis.
- Must be 18 years or older.
- Must be in good overall health, with a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Must have adequate organ and blood function as determined by specific medical tests.
- Women and men must agree to use effective birth control during the study and for a specified period after the last dose of treatment.
- Must be able to understand and sign a consent form agreeing to participate in the study.
Exclusion Criteria
- Cannot have other types of nasal or sinus cancers not included in the study, such as angiosarcomas or lymphomas.
- Cannot have cancer that cannot be surgically removed.
- Cannot have cancer that has spread to distant parts of the body.
- Cannot have received certain types of immunotherapy before.
- Cannot have received a live vaccine within 30 days before starting the study.
- Cannot have an immune deficiency or be on high doses of steroids or other immune-suppressing treatments.
- Cannot have another active cancer that has required treatment in the past two years, with some exceptions.
- Cannot have an active autoimmune disease requiring treatment in the past six months.
- Cannot have a history of lung diseases like pneumonitis that required steroids.
- Cannot have uncontrolled HIV infection.
- Cannot have active hepatitis B or C infections.
- Cannot have had a tissue or organ transplant.
- Cannot be pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Brigham and Women's Hospital | 02115 | Boston | Massachusetts |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
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