Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, High-risk Salivary Duct Carcinoma

Официальное название

Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, High-risk Salivary Duct Carcinoma: a Single-arm Phase 2 Trial

Обзор

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.

Вмешательства

• Препарат Rezvilutamide
  Rezvilutamide 240 mg (3\*80mg tablets) will be administered orally once daily with or without food.
• Препарат Leuprolide Acetate
  The dose and frequency of administration will be consistent with the prescribing information in prostate cancer patients.

Первичные конечные точки

• 3-year disease-free survival (DFS) [Срок оценки: 36 months]

Вторичные конечные точки (5)

• 3-year overall survival (OS) [Срок оценки: 36 months, 60 months]
• 3-year disease-specific survival (DSS) [Срок оценки: 36 months, 60 months]
• 3-year distant-metastatic free survival (DMFS) [Срок оценки: 36 months, 60 months]
• Adverse events [Срок оценки: 36 months]
• 5-year disease-free survival (DFS) [Срок оценки: 60 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Peking University First Hospital — Пекин
• Peking University School and Hospital of Stomatology — Пекин

Идентификаторы

NCT: NCT06348264 · SDC-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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