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| Name | Class |
|---|---|
| Jiangsu Hengrui Pharmaceutical Co., Ltd. | INDUSTRY |
| Beijing Biote Pharmaceutical Co.,Ltd | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rezvilutamide plus LHRHa | Experimental | Participants will receive rezvilutamide in combination with a LHRHa for up to 2 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rezvilutamide | Drug | Rezvilutamide 240 mg (3*80mg tablets) will be administered orally once daily with or without food. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3-year disease-free survival (DFS) | DFS is defined as the time from entry until disease recurrence or death | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year overall survival (OS) | OS is defined as the time from entry until death due to any cause | 36 months, 60 months |
| 3-year disease-specific survival (DSS) | DSS is defined as the time from entry until disease-specific death |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
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| Leuprolide Acetate | Drug | The dose and frequency of administration will be consistent with the prescribing information in prostate cancer patients. |
|
| 36 months, 60 months |
| 3-year distant-metastatic free survival (DMFS) | DMFS is defined as the time from entry until distant metastasis or death | 36 months, 60 months |
| Adverse events | Evaluate adverse events utilizing CTCAE V5 | 36 months |
| 5-year disease-free survival (DFS) | DFS is defined as the time from entry until disease recurrence or death | 60 months |
| Peking University School and Hospital of Stomatology | Recruiting | Beijing | Beijing Municipality | China |
|
| ID | Term |
|---|---|
| D016729 | Leuprolide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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