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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Rezvilutamide 240 mg (3\*80mg tablets) will be administered orally once daily with or without food.
The dose and frequency of administration will be consistent with the prescribing information in prostate cancer patients.
Peking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGPeking University School and Hospital of Stomatology
Beijing, Beijing Municipality, China
RECRUITING3-year disease-free survival (DFS)
DFS is defined as the time from entry until disease recurrence or death
Time frame: 36 months
3-year overall survival (OS)
OS is defined as the time from entry until death due to any cause
Time frame: 36 months, 60 months
3-year disease-specific survival (DSS)
DSS is defined as the time from entry until disease-specific death
Time frame: 36 months, 60 months
3-year distant-metastatic free survival (DMFS)
DMFS is defined as the time from entry until distant metastasis or death
Time frame: 36 months, 60 months
Adverse events
Evaluate adverse events utilizing CTCAE V5
Time frame: 36 months
5-year disease-free survival (DFS)
DFS is defined as the time from entry until disease recurrence or death
Time frame: 60 months
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