Actively Recruiting
Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, High-risk Salivary Duct Carcinoma
Led by Peking University First Hospital · Updated on 2025-09-23
37
Participants Needed
2
Research Sites
337 weeks
Total Duration
On this page
Sponsors
P
Peking University First Hospital
Lead Sponsor
J
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, High-risk Salivary Duct Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form provided
- Willingness to follow all study procedures and be available for the study duration
- Histologically confirmed salivary duct carcinoma at stage III, IVa, or IVb
- Surgery for salivary duct carcinoma completed and adjuvant radiotherapy planned, ongoing, or completed
- Positive for androgen receptor (AR)
- White blood cell count 3.0 x 10^9/L
- Neutrophil count 1.5 x 10^9/L
- Platelet count 75 x 10^9/L
- Hemoglobin 90 g/L
- Serum creatinine less than 1.5 times upper limit of normal or creatinine clearance 50 ml/min
- Total bilirubin less than 1.5 times upper limit of normal
- AST less than 2.5 times upper limit of normal
- ALT less than 2.5 times upper limit of normal
- ECOG performance status 0, 1, or 2 and able to take oral medication
- Females of reproductive potential must use highly effective contraception for at least 1 month before screening and during study participation plus 1 year after treatment ends
- Males of reproductive potential must use condoms or other effective contraception methods with partner
You will not qualify if you...
- Prior anti-androgen receptor pathway therapy received
- Treatment with another investigational drug or chemotherapy in the past 6 months
- History of hypothalamus or pituitary dysfunction
- History of seizures
- Clinically uncontrolled diseases such as septic shock, uncontrolled hypertension, unstable angina, NYHA class III or IV heart disease, clinically unstable arrhythmia, or recent myocardial infarction (within 6 months)
- Previous cancer except non-melanoma skin cancer or cancer cured more than 5 years ago
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
2
Peking University School and Hospital of Stomatology
Beijing, Beijing Municipality, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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