Exploratory Study of Molecular Profile-Associated Evidence Guided Precision Therapy for Salivary Gland Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Pyrotinib
- Conditions
- Salivary Gland Neoplasms
- Sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Enrollment
- 182
- Locations
- 1
- Primary Endpoint
- Molecular mutation profile of patients with salivary gland cancer
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Locally advanced patients with molecular-guided therapy
Locally advanced patient will be assigned to molecularly-guided therapy based on genomic profile.
Intervention: Pyrotinib
Locally advanced patients with molecular-guided therapy
Locally advanced patient will be assigned to molecularly-guided therapy based on genomic profile.
Intervention: Bicalutamide
Locally advanced patients with molecular-guided therapy
Locally advanced patient will be assigned to molecularly-guided therapy based on genomic profile.
Intervention: Leuprorelin
Advanced patients with molecular-guided therapy
Advanced patient will be assigned to molecularly-guided therapy based on genomic profile.
Intervention: Pyrotinib
Advanced patients with molecular-guided therapy
Advanced patient will be assigned to molecularly-guided therapy based on genomic profile.
Intervention: Bicalutamide
Advanced patients with molecular-guided therapy
Advanced patient will be assigned to molecularly-guided therapy based on genomic profile.
Intervention: Leuprorelin
Outcomes
Primary Outcomes
Molecular mutation profile of patients with salivary gland cancer
Time Frame: 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
Time Frame: 18 months
Proportion of patients who have actionable genomic alterations and receive matched therapy based on genomic profile(s)
Secondary Outcomes
- Progression-free survival (PFS) in patients(2 years)
- Objective Response Rate (ORR)(2 years)
- Overall Survival (OS)(2 years)
- Proportion of patients with actionable genomic alteration(2 years)
- Treatment-related adverse events (AEs)(2 years)