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.
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.
Study Type
OBSERVATIONAL
Enrollment
182
Pyrotinib 400mg qd po
Bicalutamide was administered orally at a daily dose of 50 mg
Leuprorelin acetate was administered subcutaneously at a dose of 3.75 mg every 4 weeks
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
RECRUITINGMolecular mutation profile of patients with salivary gland cancer
To explore the complete picture of molecular mutations in locally advanced and advanced salivary gland tumors in China
Time frame: 18 months
Proportion of patients who receive molecular guided therapy
Proportion of patients who have actionable genomic alterations and receive matched therapy based on genomic profile(s)
Time frame: 18 months
Progression-free survival (PFS) in patients
PFS of patients with locally advanced and advanced salivary gland cancer
Time frame: 2 years
Objective Response Rate (ORR)
ORR in patients with advanced salivary gland cancer
Time frame: 2 years
Overall Survival (OS)
OS of patients with locally advanced and advanced salivary gland cancer
Time frame: 2 years
Proportion of patients with actionable genomic alteration
To calculate the proportion of patients with actionable genomic alteration(s)
Time frame: 2 years
Treatment-related adverse events (AEs)
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
Time frame: 2 years
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