Salivary Gland Neoplasms
Conditions
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.
Interventions
DRUGPyrotinib
Pyrotinib 400mg qd po
DRUGBicalutamide
Bicalutamide was administered orally at a daily dose of 50 mg
DRUGLeuprorelin
Leuprorelin acetate was administered subcutaneously at a dose of 3.75 mg every 4 weeks
Sponsors
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with actionable genomic alteration | 2 years | To calculate the proportion of patients with actionable genomic alteration(s) |
| Objective Response Rate (ORR) | 2 years | ORR in patients with advanced salivary gland cancer |
| Progression-free survival (PFS) in patients | 2 years | PFS of patients with locally advanced and advanced salivary gland cancer |
| 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 |
| Overall Survival (OS) | 2 years | OS of patients with locally advanced and advanced salivary gland cancer |
Countries
China
Contacts
Primary ContactGuopei Zhu, M.D.
Outcome results
None listed