NCT06348264

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Salivary Gland Neoplasm Duct

Interventions

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

Timeline

• Start date: 2024-10-10
• Primary completion: 2029-03-30
• Completion: 2031-03-30
• First posted: 2024-04-04
• Last updated: 2025-09-23

Locations

2 sites across 1 country: China