NCT06348264招募中2 期
Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, High-risk Salivary Duct Carcinoma: a Single-arm Phase 2 Trial
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- 3-year disease-free survival (DFS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Rezvilutamide plus LHRHa
Experimental
Participants will receive rezvilutamide in combination with a LHRHa for up to 2 years.
干预措施: Rezvilutamide (Drug)
Rezvilutamide plus LHRHa
Experimental
Participants will receive rezvilutamide in combination with a LHRHa for up to 2 years.
干预措施: Leuprolide Acetate (Drug)
结局指标
主要结局
3-year disease-free survival (DFS)
时间窗: 36 months
DFS is defined as the time from entry until disease recurrence or death
次要结局
- 3-year disease-specific survival (DSS)(36 months, 60 months)
- 3-year overall survival (OS)(36 months, 60 months)
- 3-year distant-metastatic free survival (DMFS)(36 months, 60 months)
- Adverse events(36 months)
- 5-year disease-free survival (DFS)(60 months)
研究者
研究点 (2)
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