Salivary Gland NeoplasmsMAPSNCT05087706
Exploratory Study of Molecular Profile-Associated Evidence Guided Precision Therapy for Salivary Gland Cancer（MAPS）
An observational study of Salivary Gland Neoplasms, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Salivary Gland Neoplasms
- What is being tested?
- Pyrotinib, Bicalutamide and Leuprorelin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 182 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2021to 19 Sep 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients interviewed at Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200011
Guopei Zhu, M.D., antica@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Salivary Gland Neoplasms
- Being tested
- Pyrotinib, Bicalutamide, Leuprorelin
- Medical subject headings
- Salivary Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyrotinibDrug
Pyrotinib 400mg qd po
BicalutamideDrug
Bicalutamide was administered orally at a daily dose of 50 mg
LeuprorelinDrug
Leuprorelin acetate was administered subcutaneously at a dose of 3.75 mg every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Locally advanced patients with molecular-guided therapy | Locally advanced patient will be assigned to molecularly-guided therapy based on genomic profile. Receives: 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. Receives: Drug: Pyrotinib; Drug: Bicalutamide; Drug: Leuprorelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 18 months
Secondary outcomes (5)
Progression-free survival (PFS) in patients
PFS of patients with locally advanced and advanced salivary gland cancer
Measured: 2 years
Objective Response Rate (ORR)
ORR in patients with advanced salivary gland cancer
Measured: 2 years
Overall Survival (OS)
OS of patients with locally advanced and advanced salivary gland cancer
Measured: 2 years
Proportion of patients with actionable genomic alteration
To calculate the proportion of patients with actionable genomic alteration(s)
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start30 Jul 2021
- Primary completion19 Mar 2023 (estimated)
- Study completion19 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salivary Gland NeoplasmsStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 182 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087706
- Sponsor's protocol ID
- 2021HNRT03
- Acronym
- MAPS
- Status last verified
- Oct 2021
- First submitted
- 22 Sep 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Molecular Profile-Associated Evidence Guided Precision Therapy for Salivary Gland Cancer
- ClinicalTrials.gov ID
- NCT05087706
- Acronym / sponsor ID
- MAPS / 2021HNRT03
- Conditions
- Salivary Gland Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 19 Mar 2023 (estimated)
- Study completion
- 19 Sep 2023 (estimated)
- First posted
- 21 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Locally advanced patients with molecular-guided therapy | – | Drug: Pyrotinib, Drug: Bicalutamide, Drug: LeuprorelinLocally advanced patient will be assigned to molecularly-guided therapy based on genomic profile. |
| Advanced patients with molecular-guided therapy | – | Drug: Pyrotinib, Drug: Bicalutamide, Drug: LeuprorelinAdvanced patient will be assigned to molecularly-guided therapy based on genomic profile. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients interviewed at Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PyrotinibPyrotinib 400mg qd po | Drug | Advanced patients with molecular-guided therapy, Locally advanced patients with molecular-guided therapy |
| BicalutamideBicalutamide was administered orally at a daily dose of 50 mg | Drug | Advanced patients with molecular-guided therapy, Locally advanced patients with molecular-guided therapy |
| LeuprorelinLeuprorelin acetate was administered subcutaneously at a dose of 3.75 mg every 4 weeks | Drug | Advanced patients with molecular-guided therapy, Locally advanced patients with molecular-guided therapy |
Primary outcome
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
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)
5 secondary outcomes
Progression-free survival (PFS) in patients
Time frame: 2 years
Objective Response Rate (ORR)
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
Proportion of patients with actionable genomic alteration
Time frame: 2 years
Treatment-related adverse events (AEs)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Salivary Gland Neoplasms, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guopei Zhu, M.D. (15800386875, antica@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular mutation profile of patients with salivary gland cancer (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.