Exploratory Study of PD-1 Neoadjuvant Treatment of Recurrent Meningioma

  • STATUS
    Recruiting
  • End date
    Jun 1, 2025
  • participants needed
    15
  • sponsor
    Beijing Tiantan Hospital
Updated on 19 August 2021
dexamethasone
tumor cells
recurrent meningioma

Summary

This research study is studying a drug as a possible treatment for High Grade Meningioma.

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.

Details
Condition malignant meningioma, Meningioma, Meningiomas
Treatment Sintilimab
Clinical Study IdentifierNCT04728568
SponsorBeijing Tiantan Hospital
Last Modified on19 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Pathologically diagnosed as a patient with WHO grade III recurrent meningioma
Age 18 years
Kps70
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
Clear my responses

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Step 1 Connect with a study center
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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