Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, High-risk Salivary Duct Carcinoma
NCT ID: NCT06348264
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
37 participants
INTERVENTIONAL
2024-10-10
2031-03-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rezvilutamide plus LHRHa
Participants will receive rezvilutamide in combination with a LHRHa for up to 2 years.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Jiangsu Hengrui Pharmaceutical Co., Ltd.
INDUSTRY
Beijing Biote Pharmaceutical Co.,Ltd
UNKNOWN
Peking University First Hospital
OTHER
Responsible Party
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Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University School and Hospital of Stomatology
Beijing, Beijing Municipality, China
Countries
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Facility Contacts
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Other Identifiers
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SDC-1
Identifier Type: -
Identifier Source: org_study_id
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