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Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, High-risk Salivary Duct Carcinoma
Sponsor: Peking University First Hospital
Summary
The purpose of the study is to evaluate the efficacy and safety of rezvilutamide in combination with androgen deprivation therapy (ADT) in participants with androgen receptor (AR) positive, high-risk salivary duct carcinoma (SDC). The procedures include screening, treatment and follow-up period. The treatment includes rezvilutamide plus Luteinizing Hormone Releasing Hormone agonist (LHRHa) for up to 2 years.
Official title: Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, High-risk Salivary Duct Carcinoma: a Single-arm Phase 2 Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
37
Start Date
2024-10-10
Completion Date
2031-03-30
Last Updated
2025-09-23
Healthy Volunteers
No
Conditions
Interventions
Rezvilutamide
Rezvilutamide 240 mg (3\*80mg tablets) will be administered orally once daily with or without food.
Leuprolide Acetate
The dose and frequency of administration will be consistent with the prescribing information in prostate cancer patients.
Locations (2)
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University School and Hospital of Stomatology
Beijing, Beijing Municipality, China