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

NCT ID: NCT05087706

Last Updated: 2021-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

182 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-30

Study Completion Date

2023-09-19

Brief Summary

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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

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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.

Conditions

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Salivary Gland Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Locally advanced patients with molecular-guided therapy

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

Pyrotinib

Intervention Type DRUG

Pyrotinib 400mg qd po

Bicalutamide

Intervention Type DRUG

Bicalutamide was administered orally at a daily dose of 50 mg

Leuprorelin

Intervention Type DRUG

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.

Pyrotinib

Intervention Type DRUG

Pyrotinib 400mg qd po

Bicalutamide

Intervention Type DRUG

Bicalutamide was administered orally at a daily dose of 50 mg

Leuprorelin

Intervention Type DRUG

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

Interventions

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Pyrotinib

Pyrotinib 400mg qd po

Intervention Type DRUG

Bicalutamide

Bicalutamide was administered orally at a daily dose of 50 mg

Intervention Type DRUG

Leuprorelin

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
* 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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guopei Zhu, M.D.

Role: CONTACT

[email protected]
15800386875

Facility Contacts

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Guopei Zhu, M.D.

Role: primary

[email protected]

Other Identifiers

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2021HNRT03

Identifier Type: -

Identifier Source: org_study_id