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

NCT05087706 | Unknown

• 1 other identifier: 2021HNRT03
• Study Type: observational
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Salivary Gland Neoplasms

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Progression-free survival (PFS) in patients

  2 years

• Objective Response Rate (ORR)

  2 years

• Overall Survival (OS)

  2 years

• Proportion of patients with actionable genomic alteration

  2 years

• Treatment-related adverse events (AEs)

  2 years

Study Arms (2)

Locally advanced patients with molecular-guided therapy

Locally advanced patient will be assigned to molecularly-guided therapy based on genomic profile.

Drug: Pyrotinib; Drug: Bicalutamide; Drug: Leuprorelin

Advanced patients with molecular-guided therapy

Advanced patient will be assigned to molecularly-guided therapy based on genomic profile.

Drug: Pyrotinib; Drug: Bicalutamide; Drug: Leuprorelin

Interventions

Pyrotinib DRUG

Pyrotinib 400mg qd po

Advanced patients with molecular-guided therapy; Locally advanced patients with molecular-guided therapy

Bicalutamide DRUG

Bicalutamide was administered orally at a daily dose of 50 mg

Advanced patients with molecular-guided therapy; Locally advanced patients with molecular-guided therapy

Leuprorelin DRUG

Leuprorelin acetate was administered subcutaneously at a dose of 3.75 mg every 4 weeks

Advanced patients with molecular-guided therapy; Locally advanced patients with molecular-guided therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• Histologically confirmed recurrent or metastatic salivary gland cancer, the main pathological subtypes include:
• Mucoepidermoid carcinoma
• Salivary duct carcinoma
• Non-specific adenocarcinoma
• Mastoid secretory carcinoma

You may not qualify if:

• 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 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

Sponsors & Collaborators

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

Study Sites (1)

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

MeSH Terms

Conditions

Salivary Gland Neoplasms

Interventions

pyrotinib; bicalutamide; Leuprolide

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Central Study Contacts

Guopei Zhu, M.D.

CONTACT

15800386875; antica@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 21, 2021
• Study Start: July 30, 2021
• Primary Completion: March 19, 2023
• Study Completion: September 19, 2023
• Last Updated: October 21, 2021

Record last verified: 2021-10

Locations

CN (1)