Exploratory Study of Molecular Profile-Associated Evidence Guided Precision Therapy for Salivary Gland Cancer（MAPS）
- Conditions
- Salivary Gland Neoplasms
- Interventions
- Registration Number
- NCT05087706
- Lead Sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Brief Summary
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.
- Detailed Description
This is a prospective, open-label, non-randomized single-center study to evaluate the feasibility of using molecular profile-based evidence to guide personalized therapy for patients with incurable salivary gland carcinoma patients. Comprehensive Genomic Profiling is performed on tissue with assessment of tumor mutation burden (TMB) status, and additional PD-L1 immunohistochemistry testing. Study Committee or Molecular Tumor Board (MTB) will recommend matched therapy, if available, following analysis of patient genomic profiles. The final treatment administered will be based on the treating physician's choice with MTB advice, patient preference, comorbidity considerations, and available drug access. Access to medication followed real-world practice.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 182
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Locally advanced patients with molecular-guided therapy Bicalutamide Locally advanced patient will be assigned to molecularly-guided therapy based on genomic profile. Locally advanced patients with molecular-guided therapy Pyrotinib Locally advanced patient will be assigned to molecularly-guided therapy based on genomic profile. Locally advanced patients with molecular-guided therapy Leuprorelin Locally advanced patient will be assigned to molecularly-guided therapy based on genomic profile. Advanced patients with molecular-guided therapy Pyrotinib Advanced patient will be assigned to molecularly-guided therapy based on genomic profile. Advanced patients with molecular-guided therapy Bicalutamide Advanced patient will be assigned to molecularly-guided therapy based on genomic profile. Advanced patients with molecular-guided therapy Leuprorelin Advanced patient will be assigned to molecularly-guided therapy based on genomic profile.
- Primary Outcome Measures
Name Time Method Molecular mutation profile of patients with salivary gland cancer 18 months To explore the complete picture of molecular mutations in locally advanced and advanced salivary gland tumors in China
Proportion of patients who receive molecular guided therapy 18 months Proportion of patients who have actionable genomic alterations and receive matched therapy based on genomic profile(s)
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) in patients 2 years PFS of patients with locally advanced and advanced salivary gland cancer
Objective Response Rate (ORR) 2 years ORR in patients with advanced salivary gland cancer
Overall Survival (OS) 2 years OS of patients with locally advanced and advanced salivary gland cancer
Proportion of patients with actionable genomic alteration 2 years To calculate the proportion of patients with actionable genomic alteration(s)
Treatment-related adverse events (AEs) 2 years The grade of AEs and the number of patients with AEs are assessed by the investigator based on CTCAE v5.0 from the date of enrollment to 90 days after last dose of study treatment
Trial Locations
- Locations (1)
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
🇨🇳Shanghai, Shanghai, China