Exploring PD-1 treatment for recurrent malignant meningioma
Exploratory Study of PD-1 Neoadjuvant Treatment of Recurrent Meningioma
This study is testing if a new treatment called Sintilimab can help patients with recurrent high-grade meningioma by boosting their immune system before surgery to improve their chances of survival.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT04728568 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of Sintilimab, a PD-1 antibody, as a neoadjuvant treatment for patients with recurrent high-grade meningioma. Meningiomas are common brain tumors, and while many are benign, high-grade variants can recur and have poor outcomes. The research aims to assess whether preoperative PD-1 therapy can enhance immune function and improve survival rates in these patients. Various advanced techniques, including flow cytometry and T cell receptor sequencing, will be employed to evaluate immune responses.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a pathologically confirmed diagnosis of WHO grade III recurrent meningioma.
Not a fit: Patients with prior treatment using anti-PD-1 agents or those with significant immunodeficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival and immune response in patients with recurrent malignant meningioma.
How similar studies have performed: While the application of PD-1 therapy in recurrent meningioma is rarely reported, immunotherapy has shown promising results in treating other solid tumors.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing
- Beijing TianTan Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Feng Chen — Beijing Tiantan Hospital
- Study coordinator: Feng Chen
- Email: chenfeng@bjtth.org
- Phone: 59975034
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.