Exploratory Study of Molecular Profile-Associated Evidence Guided Precision Therapy for Salivary Gland Cancer（MAPS） (MAPS)

Exploratory Study of Molecular Profile-Associated Evidence Guided Precision Therapy for Salivary Gland Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Salivary Gland Neoplasms
• Intervention / Treatment: Drug: Pyrotinib; Drug: Bicalutamide; Drug: Leuprorelin

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.

• Study Type: Observational
• Enrollment (Anticipated): 182

Contacts and Locations

• Study Contact: Name: Guopei Zhu, M.D.; Phone Number: 15800386875; Email: antica@gmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Recruiting
      • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
      • Contact: Guopei Zhu, M.D.; Email: antica@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients interviewed at Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Locally advanced patients with molecular-guided therapy; Locally advanced patient will be assigned to molecularly-guided therapy based on genomic profile.	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
Advanced patients with molecular-guided therapy; Advanced patient will be assigned to molecularly-guided therapy based on genomic profile.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Molecular 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	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)	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS) in patients	PFS of patients with locally advanced and advanced salivary gland cancer	2 years
Objective Response Rate (ORR)	ORR in patients with advanced salivary gland cancer	2 years
Overall Survival (OS)	OS of patients with locally advanced and advanced salivary gland cancer	2 years
Proportion of patients with actionable genomic alteration	To calculate the proportion of patients with actionable genomic alteration(s)	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	2 years

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2021
• Primary Completion (Anticipated): March 19, 2023
• Study Completion (Anticipated): September 19, 2023

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: October 8, 2021
• First Posted (Actual): October 21, 2021

Study Record Updates

• Last Update Posted (Actual): October 21, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Mouth Neoplasms; Salivary Gland Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Androgen Antagonists; Leuprolide; Bicalutamide
• Other Study ID Numbers: 2021HNRT03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No