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

Salivary Gland Neoplasms Clinical Trial

— MAPS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05087706
• Other study ID #: 2021HNRT03
• Status: Recruiting
• Start date: July 30, 2021
• Est. completion date: September 19, 2023

Study information

• Verified date: October 2021
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: Guopei Zhu, M.D.
• Phone: 15800386875
• Email: antica[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: September 19, 2023
• Est. primary completion date: March 19, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Salivary Gland Neoplasms

Intervention

Drug:
• Pyrotinib
Pyrotinib 400mg qd po
• Bicalutamide
Bicalutamide was administered orally at a daily dose of 50 mg
• Leuprorelin
Leuprorelin acetate was administered subcutaneously at a dose of 3.75 mg every 4 weeks

Locations

Country	Name	City	State
China	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

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