Targeted treatment for advanced salivary gland cancer based on genetic profiling

Cancer Hospital, Chinese Academy of Medical Sciences/National Cancer Center of China

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: PHASE2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Peking Union Medical College (other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT06145308 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 or older with a histopathologic diagnosis of salivary gland carcinoma and measurable lesions.

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.

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 performed: Other studies have shown promise in using precision medicine approaches for various cancers, suggesting potential success for this novel application in salivary gland carcinoma.

Eligibility 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 this trial is running

Beijing, Beijing Municipality and 1 other locations

• 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

Conditions: Salivary Gland Carcinoma, Precision Therapy