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

What Was Tested

This registered phase 2 trial tested Leuprolide.

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.

It had 1 arm (groups): Rezvilutamide plus LHRHa (experimental).

Participants will receive rezvilutamide in combination with a LHRHa for up to 2 years.

The registry classes the interventions as drug.

Who Took Part

37 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 11 inclusion and 7 exclusion criteria; among the exclusions: received prior anti-ar pathway therapy; treatment with another investigational drug or chemotherapy within 6 months; history of hypothalamus or pituitary dysfunction.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Leuprolide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2024-10-10 with completion listed for 2029-03-30.

It ran at 2 sites in China (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 3-year disease-free survival (DFS) (time frame: 36 months).

It also tracked 5 secondary outcomes, for example 3-year overall survival (OS), 3-year disease-specific survival (DSS), 3-year distant-metastatic free survival (DMFS), Adverse events and 5-year disease-free survival (DFS).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Leuprolide in 37 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, all human trials.