Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, High-risk Salivary Duct Carcinoma
- Conditions
- Salivary Gland Neoplasm Duct
- Interventions
- Registration Number
- NCT06348264
- Lead Sponsor
- Peking University First Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 37
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Rezvilutamide plus LHRHa Leuprolide Acetate Participants will receive rezvilutamide in combination with a LHRHa for up to 2 years. Rezvilutamide plus LHRHa Rezvilutamide Participants will receive rezvilutamide in combination with a LHRHa for up to 2 years.
- Primary Outcome Measures
Name Time Method 3-year disease-free survival (DFS) 36 months DFS is defined as the time from entry until disease recurrence or death
- Secondary Outcome Measures
Name Time Method 3-year disease-specific survival (DSS) 36 months, 60 months DSS is defined as the time from entry until disease-specific death
3-year overall survival (OS) 36 months, 60 months OS is defined as the time from entry until death due to any cause
3-year distant-metastatic free survival (DMFS) 36 months, 60 months DMFS is defined as the time from entry until distant metastasis or death
Adverse events 36 months Evaluate adverse events utilizing CTCAE V5
5-year disease-free survival (DFS) 60 months DFS is defined as the time from entry until disease recurrence or death
Trial Locations
- Locations (2)
Peking University School and Hospital of Stomatology
🇨🇳Beijing, Beijing, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China