Exploratory Study of PD-1 Neoadjuvant Treatment of Recurrent Meningioma

Last updated: August 9, 2021
Sponsor: Beijing Tiantan Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Brain Cancer

Brain Tumor

Meningiomas

Treatment

N/A

Clinical Study ID

NCT04728568
320.6750.2020-10-02
  • Ages 18-70
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Participants who have had chemotherapy, targeted small molecule therapy or studytherapy 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 2weeks 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. Unableto undergo brain MRI.

Study Design

Total Participants: 15
Study Start date:
June 01, 2020
Estimated Completion Date:
June 01, 2025

Study 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.

Connect with a study center

  • Beijing TianTan Hospital

    Beijing, Beijing 100071
    China

    Active - Recruiting

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