Clinical trial · Observational
Exploratory Study of Molecular Profile-Associated Evidence Guided Precision Therapy for Salivary Gland Cancer(MAPS)
Exploratory Study of Molecular Profile-Associated Evidence Guided Precision Therapy for Salivary Gland Cancer
NCT05087706CI-TRIAL-00054598MAPSunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To explore the feasibility, efficacy and safety of determining the treatment regimen based on genomic profiling in patients with locally advanced and advanced salivary gland cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Salivary Gland Neoplasms | Salivary Gland Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bicalutamide | Drug | Bicalutamide | ALIAS |
| Leuprorelin | Drug | Leuprolide | ALIAS |
| Pyrotinib | Drug | Pyrotinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Locally advanced patients with molecular-guided therapy
- description
- Locally advanced patient will be assigned to molecularly-guided therapy based on genomic profile.
- interventionNames
- Drug: Pyrotinib
- Drug: Bicalutamide
- Drug: Leuprorelin
- label
- Advanced patients with molecular-guided therapy
- description
- Advanced patient will be assigned to molecularly-guided therapy based on genomic profile.
- interventionNames
- Drug: Pyrotinib
- Drug: Bicalutamide
- Drug: Leuprorelin
Primary outcomes (2)
- measure
- Molecular mutation profile of patients with salivary gland cancer
- timeFrame
- 18 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria for patients with locally advanced gland cancer at high-risk of recurrence must meet all entry criteria for participation in this study: * Locally advanced salivary gland carcinoma patients with high risk of recurrence confirmed by histology, the main pathological subtypes include: * Mucoepidermoid carcinoma * Salivary duct carcinoma * Non-specific adenocarcinoma * Pleomorphic adenocarcinoma, etc. * Expected survival ≥ 6 months * Patients with prior standard surgery and post-operative radiotherapy (chemotherapy) * Adequate function of main organs * Sufficient tissue samples for gene mutation test * Signed informed consent Inclusion Criteria for patients of advanced gland cancer must meet all entry criteria for participation in this study: * Histologically confirmed recurrent or metastatic salivary gland cancer, the main pathological subtypes include: * Mucoepidermoid carcinoma * Salivary duct carcinoma * Non-specific adenocarcinoma * Mastoid secretory carcinoma * Pleomorphic adenocarcinoma, etc. * a measurable lesion according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) * Expected survival ≥ 6 months * Adequate function of main organs * Sufficient tissue samples for gene mutation detection * Signed informed consent. Exclusion Criteria for patients with locally advanced disease at high-risk of recurrence who meet any of the exclusion criteria at baseline will be excluded from the study: * Severe or uncontrolled medical conditions (i.e., uncontrolled diabetes, chronic kidney disease, chronic lung disease or active uncontrolled infection, psychiatric illness/social situations that would, in the opinion of the investigator, confound the analysis of response to study treatment) * Pregnancy or breastfeeding, or any patient with childbearing potential not using adequate pregnancy prevention Exclusion Criteria for patients with advanced disease who meet any of the exclusion criteria at baseline will be excluded from the study: * Primary lesions amenable to local therapy * Severe or uncontrolled medical conditions (i.e., uncontrolled diabetes, chronic kidney disease, chronic lung disease or active uncontrolled infection, psychiatric illness/social situations that would, in the opinion of the investigator, confound the analysis of response to study treatment). * Pregnancy or breastfeeding, or any patient with childbearing potential not using adequate pregnancy prevention
References
Publications (0)
Data not yet available
No reference posted for this study.