NCT05087706

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 182 (estimated)
• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Salivary Gland Neoplasms

Interventions

Type	Name	Description
DRUG	Pyrotinib	Pyrotinib 400mg qd po
DRUG	Bicalutamide	Bicalutamide was administered orally at a daily dose of 50 mg
DRUG	Leuprorelin	Leuprorelin acetate was administered subcutaneously at a dose of 3.75 mg every 4 weeks

Timeline

• Start date: 2021-07-30
• Primary completion: 2023-03-19
• Completion: 2023-09-19
• First posted: 2021-10-21
• Last updated: 2021-10-21

Locations

1 site across 1 country: China