- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04728568
Exploratory Study of PD-1 Neoadjuvant Treatment of Recurrent Meningioma
August 9, 2021 updated by: Beijing Tiantan Hospital
This research study is studying a drug as a possible treatment for High Grade Meningioma.
Study Overview
Detailed Description
Meningioma is one of the most common primary intracranial tumors, accounting for 13% to 26% of all intracranial tumors.
Although most meningiomas are benign tumors and can be cured by surgical resection, more than 20% of WHO II (atypical) and about 3% of WHO III meningiomas are more likely to have local recurrence after initial treatment , And the lifetime is poor.
The immunotherapy represented by PD-1 has achieved remarkable efficacy in the treatment of solid tumors, but the application of PD-1 in recurrent meningioma is rarely reported.
The study found that the expression of PD-L1 mRNA and protein in high-grade meningioma cells increased, and the total number of T cells, including CD4+ and CD8+ cells, was significantly reduced, suggesting an inhibitory tumor immune microenvironment.
Recent studies have shown that giving patients anti-PD-1 antibody immunotherapy prior to conventional treatment can improve the pathological response, enable the body to produce an enhanced and sustained anti-tumor immune response, and form a tumor microenvironment conducive to immunotherapy.
Therefore, giving PD-1 antibody before surgery is a new idea for the treatment of meningiomas.
This project aims to investigate whether patients with recurrent meningioma will change their immune function and prolong survival after preoperative PD-1 antibody treatment.
It is planned to use flow cytometry, multiple immunofluorescence histochemistry technology, T cell receptor sequencing, etc to detect the changes in the patient's immune function before and after treatment, observe the pathological remission rate of PD-1 monoclonal antibody neoadjuvant treatment of recurrent meningioma, and identify potential response biomarkers, and conduct in-depth discussions on this treatment plan to further determine the treatment mode Clinical value and specific mechanism of action in order to improve the clinical treatment level of patients with recurrent meningioma.
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Not Applicable
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
- Name: Feng Chen
- Phone Number: 59975034
- Email: chenfeng@bjtth.org
Study Locations
-
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Beijing
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Beijing, Beijing, China, 100071
- Recruiting
- Beijing Tiantan Hospital
-
Contact:
- Feng Chen
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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
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Pathologically diagnosed as a patient with WHO grade III recurrent meningioma
- Age ≥ 18 years
- Kps≥70
- able to accept second surgery
- ECOG Performance Status < 2
- Glucocorticoid dosage dexamethasone ≤5mg/ day or equivalent dose
Exclusion Criteria:
- Participants who have had chemotherapy, targeted small molecule therapy or study therapy within 14 days of protocol treatment, or those who have not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 2 weeks earlier.
- Participants who are receiving any other investigational agents.
- Participants who have a diagnosis of an immunodeficiency.
- Requires treatment with high dose systemic corticosteroids defined as dexamethasone >2mg/day or bioequivalent within 7 days of initiating therapy.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. Unable to undergo brain MRI.
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
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sintilimab
Sintilimab will be administered every 3 weeks Sintilimab will be administered through IV infusion
|
Sintilimab binds to PD-1, an inhibitory signaling receptor expressed on the surface of activated T cells, and blocks the binding to and activation of PD-1 by its ligands, which results in the activation of T-cell-mediated immune responses against tumor cells
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival
Time Frame: Every 6 weeks, up to 6 months
|
Contrast-enhanced cranial MRI will be performed every 6 weeks.
PFS6 is defined as not having progressive disease or death within six months of the first day of treatment.
Contrast-enhanced cranial magnetic resonance imaging (MRI) will be performed every 6 weeks.
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Every 6 weeks, up to 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: 6 months and 12 months
|
The distributions of overall survival will be summarized using the method of Kaplan-Meier.
The follow-up of patients who are alive at the time of analysis will be censored at the date of last assessment of vital status.
Median OS will be presented and accompanied by 90% confidence intervals estimated using log(-log(survival)) methodology.
Survival point estimates at 3 and 6 months will also be presented with confidence intervals.
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6 months and 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Feng Chen, Beijing Tiantan Hospital
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)
June 1, 2020
Primary Completion (Anticipated)
June 1, 2023
Study Completion (Anticipated)
June 1, 2025
Study Registration Dates
First Submitted
January 25, 2021
First Submitted That Met QC Criteria
January 25, 2021
First Posted (Actual)
January 28, 2021
Study Record Updates
Last Update Posted (Actual)
August 10, 2021
Last Update Submitted That Met QC Criteria
August 9, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 320.6750.2020-10-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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