Clinical trial NCT05087706: Exploratory Study of Molecular Profile-Associated Evidence Guided Precision Therapy for Salivary Gland Cancer（MAPS）
Official title: Exploratory Study of Molecular Profile-Associated Evidence Guided Precision Therapy for Salivary Gland Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Salivary Gland Neoplasms
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients interviewed at 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.

Eligibility criteria: 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 exclusion criteria at baseline will be excluded from the study:

* Severe or uncontrolled medical conditions (i.e., uncontrolled diabetes, chronic kidney disease, chronic lung disease or active uncontrolled infection, psychiatric illness/social situations that would, in the opinion of the investigator, confound the analysis of response to study treatment)
* Pregnancy or breastfeeding, or any patient with childbearing potential not using adequate pregnancy prevention

Exclusion Criteria for patients with advanced disease who meet any of the exclusion criteria at baseline will be excluded from the study:

* Primary lesions amenable to local therapy
* Severe or uncontrolled medical conditions (i.e., uncontrolled diabetes, chronic kidney disease, chronic lung disease or active uncontrolled infection, psychiatric illness/social situations that would, in the opinion of the investigator, confound the analysis of response to study treatment).
* Pregnancy or breastfeeding, or any patient with childbearing potential not using adequate pregnancy prevention

Primary outcomes:
measure: Molecular mutation profile of patients with salivary gland cancer
timeFrame: 18 months
measure: Proportion of patients who receive molecular guided therapy
timeFrame: 18 months
Secondary outcomes:
measure: Progression-free survival (PFS) in patients
timeFrame: 2 years
measure: Objective Response Rate (ORR)
timeFrame: 2 years
measure: Overall Survival (OS)
timeFrame: 2 years
measure: Proportion of patients with actionable genomic alteration
timeFrame: 2 years
measure: Treatment-related adverse events (AEs)
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
state: Shanghai
Study officials:
References: