Clinical trial · Interventional
Exploratory Study of PD-1 Neoadjuvant Treatment of Recurrent Meningioma
NCT04728568CI-TRIAL-00053185unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This research study is studying a drug as a possible treatment for High Grade Meningioma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Meningioma, Malignant | Grade 3 Meningioma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sintilimab | Drug | Sintilimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sintilimab
- description
- Sintilimab will be administered every 3 weeks Sintilimab will be administered through IV infusion
- interventionNames
- Drug: Sintilimab
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- Every 6 weeks, up to 6 months
- description
- 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.
Secondary outcomes (1)
- measure
- Overall Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDWang Y, Wang C, Yin S, Yu C, Li X, Kang X, Yang S, Xie W, Lin Y, Wu Z, Li W, Chen F. Phase 2 Trial of PD-1 Inhibitor Sintilimab in Recurrent/Progressive Meningioma. CNS Neurosci Ther. 2025 Dec;31(12):e70659. doi: 10.1111/cns.70659. PMID 41358608