Clinical trial NCT06348264: Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Salivary Gland Neoplasm Duct
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Jiangsu Hengrui Pharmaceutical Co., Ltd.
name: Beijing Biote Pharmaceutical Co.,Ltd
First posted: 2024-04-04
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Primary outcomes:
measure: 3-year disease-free survival (DFS)
timeFrame: 36 months
Secondary outcomes:
measure: 3-year overall survival (OS)
timeFrame: 36 months, 60 months
measure: 3-year disease-specific survival (DSS)
timeFrame: 36 months, 60 months
measure: 3-year distant-metastatic free survival (DMFS)
timeFrame: 36 months, 60 months
measure: Adverse events
timeFrame: 36 months
measure: 5-year disease-free survival (DFS)
timeFrame: 60 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University School and Hospital of Stomatology
state: Beijing
Study officials:
References: