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RECRUITING
NCT06348264
PHASE2

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

Sponsor: Peking University First Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

37

Start Date

2024-10-10

Completion Date

2031-03-30

Last Updated

2025-09-23

Healthy Volunteers

No

Interventions

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.

Locations (2)

Peking University First Hospital

Beijing, Beijing Municipality, China

Peking University School and Hospital of Stomatology

Beijing, Beijing Municipality, China