NCT06348264 Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, High-risk Salivary Duct Carcinoma
| NCT ID | NCT06348264 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Peking University First Hospital |
| Condition | Salivary Gland Neoplasm Duct |
| Study Type | INTERVENTIONAL |
| Enrollment | 37 participants |
| Start Date | 2024-10-10 |
| Primary Completion | 2029-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 37 participants in total. It began in 2024-10-10 with a primary completion date of 2029-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Frequently Asked Questions
Who can join the NCT06348264 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Salivary Gland Neoplasm Duct. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06348264 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06348264 currently recruiting?
Yes, NCT06348264 is actively recruiting participants. Visit ClinicalTrials.gov or contact Peking University First Hospital to inquire about joining.
Where is the NCT06348264 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China.
Who is sponsoring the NCT06348264 clinical trial?
NCT06348264 is sponsored by Peking University First Hospital. The trial plans to enroll 37 participants.