Combining rezvilutamide with hormone therapy for high-risk salivary duct carcinoma
Official title: Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, High-risk Salivary Duct Carcinoma: a Single-arm Phase 2 Trial
Run by Peking University First Hospital · NCT06348264 · Data updated 2026-11-12
This study is testing if adding a new drug called rezvilutamide to hormone therapy can help people with high-risk salivary duct carcinoma feel better and improve their chances of recovery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 37 (estimated) |
| Sponsor | Peking University First Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Status | Recruiting |
| Started | October 10, 2024 |
| Main results expected | March 30, 2029 |
| Study ends | March 30, 2031 |
| Registry record updated | September 23, 2025 |
| Trial ID | NCT06348264 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals with histologically confirmed androgen receptor-positive salivary duct carcinoma who have undergone surgery and are at stage III or IV.
✕Probably not a fit
Patients with non-androgen receptor-positive salivary duct carcinoma or those who have not completed necessary surgical and radiotherapy treatments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness and safety of rezvilutamide when used alongside androgen deprivation therapy (ADT) in patients with androgen receptor-positive, high-risk salivary duct carcinoma. Participants will undergo screening, treatment, and follow-up over a period of up to two years. The treatment regimen includes rezvilutamide and a Luteinizing Hormone Releasing Hormone agonist (LHRHa). The study aims to determine if this combination can improve outcomes for patients with this aggressive cancer type.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with high-risk salivary duct carcinoma, potentially improving survival rates.
How similar studies have gone: While there is limited data on this specific combination, similar approaches in targeting androgen receptor-positive cancers have shown promise in other studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Peking University First Hospital
Beijing, Beijing Municipality, China Recruiting -
Peking University School and Hospital of Stomatology
Beijing, Beijing Municipality, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.