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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Histologically confirmed salivary duct carcinoma and stage III or IVa or IVb according to AJCC Cancer Staging Manual Eighth Edition
* Completed SDC surgery, and adjuvant radiotherapy is planned or ongoing or has completed
* Androgen receptor (AR) positive
* White blood cell (WBC) ≥ 3.0 x 10\^9/L, Neutrophil count≥ 1.5 x 10\^9/L, Platelet count (PLT) ≥ 75 x 10\^9/L, Haemoglobin (Hb) ≥ 90 g/L
* Serum creatinine (Cr) \< 1.5 x upper limit of normal(ULN) or creatinine clearance ≥ 50 ml/min.
* Total bilirubin (TBIL) \< 1.5 x ULN, AST\< 2.5 x ULN, and ALT\< 2.5 x ULN
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2, and ability to take oral medication
* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 1 year after the end of study intervention administration
* For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
Exclusion Criteria:
* Received prior anti-AR pathway therapy
* Treatment with another investigational drug or chemotherapy within 6 months
* History of hypothalamus or pituitary dysfunction
* History of seizure
* Clinically uncontrolled diseases, such as septic shock, uncontrolled hypertension, unstable angina, New York Heart Association (NYHA) class III or IV heart disease, clinically unstable arrhythmia, myocardial infarction (in the past 6 months)
* Previous cancer except skin cancer rather than malignant melanoma or any cancer curatively treated \> 5 years prior to study entry
* Pregnancy or lactation
Primary outcome measure(s)
3-year disease-free survival (DFS) — 36 months DFS is defined as the time from entry until disease recurrence or death
Trial sites (2)
Facility
City
Region
Status
Peking University First Hospital
Beijing
Beijing Municipality
Recruiting
Peking University School and Hospital of Stomatology
Beijing
Beijing Municipality
Recruiting
More Peking University First Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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