Study on Toripalimab with Standard Treatment for HPV Positive Throat Cancer
Sponsor: University of Chicago
Sponsor score: 0
ClinicalTrials ID:NCT07290621
This clinical trial is testing how well the drug toripalimab works when combined with chemotherapy and followed by surgery or adjusted radiation therapy in patients with advanced HPV16-positive throat cancer.
Patient Parameters
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Program Overview
This study aims to find out if combining the drug toripalimab with chemotherapy, followed by surgery or tailored radiation therapy, can effectively treat patients with advanced HPV16-positive throat cancer. The trial is focused on patients whose cancer is located in the oropharynx and is at an advanced stage.
Eligibility Criteria
Inclusion Criteria
- Must have confirmed HPV16-positive throat cancer.
- Cancer must be located in the oropharynx, but other rare HPV-positive sites may also qualify.
- Must be 18 years or older.
- Cancer must be at a specific advanced stage, with certain tumor sizes or lymph node involvement.
- Must have measurable cancer that can be tracked by scans.
- No previous radiation or chemotherapy for head and neck cancer.
- No major surgery for head and neck cancer within 8 weeks before joining the study.
- Must be in good overall health with a performance status of 0 or 1.
- Must be eligible to receive the chemotherapy drug cisplatin.
- Must sign an informed consent form and understand the study.
- Women must not be pregnant or breastfeeding and must use effective birth control.
- Men must use effective birth control if sexually active with women who can become pregnant.
Exclusion Criteria
- Cancer has spread to distant parts of the body.
- Cancer is not HPV16 subtype.
- Primary cancer site cannot be identified.
- Have serious medical conditions that affect treatment tolerance or survival.
- Have low-risk N1 disease (small single lymph node).
- Have active autoimmune or inflammatory disorders needing immunosuppressive therapy, except for certain stable conditions.
- Have used immunosuppressive medications recently, except for specific low-dose treatments.
- Have had severe allergic reactions to similar treatments.
- Are using herbal remedies that affect the immune system or organ function.
- Have had major surgery other than minor biopsies or tumor-reducing procedures.
- Are receiving other experimental treatments.
- Have had recent systemic cancer treatment.
- Have another progressing or actively treated cancer, except for certain skin cancers or in situ cervical cancer.
- Have active lung inflammation not caused by infection.
- Have active Hepatitis B or C, unless eradicated.
- Have received a live vaccine recently.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| The University of Chicago Medicine Comprehensive Cancer Center | 60637 | Chicago | Illinois |
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