Single-Center Evaluation of the Clinical and Radiological Benefit of AHCC® in Combination with Standard of Care Treatment for HPV-Positive Patients with Head and Neck Squamous Cell Carcinoma (HNSCC)
University of California, Irvine
Summary
This is a phase 2, single-arm, open-label clinical trial determining safety and tolerability of AHCC in subjects with HPV-positive patients with Head and Neck Squamous Cell Carcinoma. These are subjects who have undergone surgery or will be undergoing surgery.
Eligibility
- Age range
- 18–79 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Between 18 and 79 years of age. * Has a diagnosis of pathologically or cytologically proven HPV positive HNSCC. * For patients who have undergone surgery, they must be registered at least 4 weeks after surgery. * For patients that have completed surgery, has a high risk disease defined as: 1. Positive Margins and/or Extra Nodal Extension (ENE) 2. Positive margins are defined as malignancy at or within 1 mm of the margin. High grade dysplasia (i.e., carcinoma in situ) at the margin is also considered positive 3. ENE may be either gross or microscopic * No evidence…
Interventions
- DrugAHCC®capsules
Given PO
Location
- Chao Family Comprehensive Cancer Center, University of California, IrvineOrange, California