Targeted treatment for advanced salivary gland cancer based on genetic profiling
Official title: Cancer Hospital, Chinese Academy of Medical Sciences/National Cancer Center of China
Run by Peking Union Medical College · NCT06145308 · Data updated 2026-11-12
This study is testing if targeted treatments based on genetic markers can help people with advanced salivary gland cancer feel better and improve their outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 39 (estimated) |
| Sponsor | Peking Union Medical College Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Status | Recruiting |
| Started | August 15, 2023 |
| Main results expected | July 10, 2028 |
| Study ends | July 10, 2028 |
| Registry record updated | April 2, 2026 |
| Trial ID | NCT06145308 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 or older with a histopathologic diagnosis of salivary gland carcinoma and measurable lesions.
✕Probably not a fit
Patients with known hypersensitivity to the study drugs or those who cannot tolerate surgery and radiotherapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial focuses on patients with locally advanced or recurrent/metastatic salivary gland carcinoma, who are categorized into groups based on specific molecular markers such as HER2, NTRK, AR, and TROP-2. Participants receive precision targeted therapies or chemotherapy, and the study evaluates the efficacy and safety of these treatments through metrics like overall response rate (ORR). Additionally, the trial employs multi-omics technology to investigate the heterogeneity of salivary carcinoma and identify biomarkers related to treatment response and prognosis. The study also aims to correlate drug sensitivity findings from ex vivo 3D tumor models with clinical outcomes.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and personalized treatment options for patients with advanced salivary gland carcinoma.
How similar studies have gone: Other studies have shown promise in using precision medicine approaches for various cancers, suggesting potential success for this novel application in salivary gland carcinoma.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Patients with histopathologic diagnosis of salivary gland carcinoma
* The tumor tissues were subjected to HER2/NTRK/AR/TROP-2 immunohistochemical staining.
* ECOG physical status 0 or 1 score in the 3 days before the first medication of the study treatment;
* Age 18 or older - no upper limit;
* Life expectancy is more than 3 months; ⑥Have at least one measurable lesion according to RECIST1.1 standards; ⑦Women of childbearing age must have a negative pregnancy test within 7 days before the first medication, and agree to receive the necessary contraceptive measures;
⑧The patient must have adequate liver, kidney, bone marrow, heart and lung and other organ functions:
⑨Understanding and voluntarily signing informed consent prior to performing any research-related evaluation/operation;
⑩Ability to comply with research visit schedules and other programmatic requirements.
Exclusion Criteria:
* Known hypersensitivity or delayed anaphylaxis to any agents in this trial;
* Major surgery had been performed within 4 weeks prior to the start of the study and did not fully recover;
* Have received a live vaccine within 4 weeks before the start of the study or plan to receive any vaccine during the study period ;
* To study the occurrence of arterial/venous thrombosis events within 6 months before medication;
* Major cardiovascular diseases;
* Is suffering from uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, interstitial lung disease, cirrhosis, etc.;
* Is suffering from an active infection that requires systemic treatment;
* History of active tuberculosis; ⑨ Positive human immunodeficiency virus (HIV) test result; ⑩ Patients with chronic hepatitis B or active hepatitis C. ⑪Conditions that the investigator believes will affect the safety or compliance of the drug therapy in this study ⑫Female/male who is pregnant or breastfeeding or who intends to give birth;
Where it's running
-
Fei Ma
Beijing, Beijing Municipality, China Recruiting -
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China Recruiting
Study contacts
- Principal investigator: Jie Zhang — Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology
- Study coordinator: fei Ma
- Email: drmafei@126.com
- Phone: 13910217780
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Abiraterone with dalpiciclib in AR-positive, HER-2 negative salivary gland cancer
This phase 2 trial tests whether combining abiraterone and dalpiciclib helps people with AR-positive, HER-2 negative salivary gland cancer that has come back or spread.
-
Combining targeted therapies for solid tumors using CDK4/6 inhibitors and anti-VEGF agents
This study is testing if combining two cancer treatments, Palbociclib and Bevacizumab, can help people with solid tumors like colorectal, breast, and ovarian cancers feel better and respond better to treatment.
-
Multi-omics analysis of progression and tumor biology in head and neck adenoid cystic carcinoma
We will test whether different tumor biology types in people with metastatic head and neck adenoid cystic carcinoma explain why some cancers grow slowly while others grow faster.
-
Implantable microdevice drug screening for salivary and head and neck cancers
This will test whether a tiny implantable microdevice can safely and quickly deliver and screen multiple cancer drugs inside salivary gland and other head and neck tumors in patients scheduled for surgical removal.
-
Evaluating Ivonescimab for advanced salivary gland cancers
This study is testing a new treatment called Ivonescimab to see if it can help people with advanced salivary gland cancers feel better and improve their health.
-
Comparing treatments for advanced HER2-positive salivary gland cancer
This study is testing if a new drug called T-DM1 works better than the usual treatment for people with advanced HER2-positive salivary gland cancer, while also looking at another drug for those with lower levels of HER2.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.