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

October 8, 2021 updated by: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
182

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200011
        • Recruiting
        • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Molecular mutation profile of patients with salivary gland cancer
Time Frame: 18 months
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
Time Frame: 18 months
Proportion of patients who have actionable genomic alterations and receive matched therapy based on genomic profile(s)
18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS) in patients
Time Frame: 2 years
PFS of patients with locally advanced and advanced salivary gland cancer
2 years
Objective Response Rate (ORR)
Time Frame: 2 years
ORR in patients with advanced salivary gland cancer
2 years
Overall Survival (OS)
Time Frame: 2 years
OS of patients with locally advanced and advanced salivary gland cancer
2 years
Proportion of patients with actionable genomic alteration
Time Frame: 2 years
To calculate the proportion of patients with actionable genomic alteration(s)
2 years
Treatment-related adverse events (AEs)
Time Frame: 2 years
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 30, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 19, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 19, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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