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Salivary Gland Neoplasm DuctPhase 2NCT06348264

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

A Phase 2 study testing Rezvilutamide and Leuprolide Acetate in people with Salivary Gland Neoplasm Duct, run by Peking University First Hospital at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Salivary Gland Neoplasm Duct
What is being tested?
Rezvilutamide and Leuprolide Acetate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
2 sitesChina
Study dates
10 Oct 2024to 30 Mar 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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
  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

China2 sites, 2 recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    Xueying Ren, MD, +86 10 83572408, xy_ren1031@126.com

    Recruiting

  • Peking University School and Hospital of Stomatology

    Beijing, Beijing Municipality

    Xiaofeng Shan, MD, +86 10 82195390, kqsxf@263.net

    Recruiting

Other trials in China

About this study

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

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.

Being tested
Rezvilutamide, Leuprolide Acetate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RezvilutamideDrug

    Rezvilutamide 240 mg (3*80mg tablets) will be administered orally once daily with or without food.

  • Leuprolide AcetateDrug

    The dose and frequency of administration will be consistent with the prescribing information in prostate cancer patients.

Study groups in NCT06348264
Study groupRoleWhat they receive
Rezvilutamide plus LHRHaExperimentalParticipants will receive rezvilutamide in combination with a LHRHa for up to 2 years.
Receives: Drug: Rezvilutamide; Drug: Leuprolide Acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 3-year disease-free survival (DFS)

    DFS is defined as the time from entry until disease recurrence or death

    Measured: 36 months

Secondary outcomes (5)

  1. 3-year overall survival (OS)

    OS is defined as the time from entry until death due to any cause

    Measured: 36 months, 60 months

  2. 3-year disease-specific survival (DSS)

    DSS is defined as the time from entry until disease-specific death

    Measured: 36 months, 60 months

  3. 3-year distant-metastatic free survival (DMFS)

    DMFS is defined as the time from entry until distant metastasis or death

    Measured: 36 months, 60 months

  4. Adverse events

    Evaluate adverse events utilizing CTCAE V5

    Measured: 36 months

  5. 5-year disease-free survival (DFS)

    DFS is defined as the time from entry until disease recurrence or death

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2024
  2. Study start10 Oct 2024
  3. Primary completion30 Mar 2029 (estimated)
  4. Study completion30 Mar 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06348264
Sponsor's protocol ID
SDC-1
Status last verified
Aug 2025
First submitted
30 Mar 2024
Last updated
23 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rezvilutamide and Leuprolide Acetate in people with Salivary Gland Neoplasm Duct, run by Peking University First Hospital at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-year disease-free survival (DFS) (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06348264.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.

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