Evidence map›Paper›PMID 41358608›Full record

Trial reportCNS neuroscience & therapeutics2025

Phase 2 Trial of PD-1 Inhibitor Sintilimab in Recurrent/Progressive Meningioma.

Yali Wang, Can Wang, Shuo Yin, Chunna Yu, Xiaojie Li, Xun Kang, Shoubo Yang, Wenting Xie, Yi Lin, Zhen Wu and 2 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in CNS neuroscience & therapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04728568 (Exploratory Study of PD-1 Neoadjuvant Treatment of Recurrent Meningioma), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04728568 naunknown statusnot on this map

Exploratory Study of PD-1 Neoadjuvant Treatment of Recurrent Meningioma

TypeinterventionalSponsorBeijing Tiantan HospitalRan2020 to 2025Enrolled15ConditionsMeningioma, MalignantArmsSintilimab
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Yali WangDepartment of Neuro-Oncology, Cancer Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.ORCID 0000-0003-2258-584X
Can WangDepartment of Neuro-Oncology, Cancer Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Shuo YinDepartment of Neuro-Oncology, Cancer Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.ORCID 0009-0002-7131-2960
Chunna YuDepartment of Neuro-Oncology, Cancer Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Xiaojie LiDepartment of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.ORCID 0000-0002-6666-9888
Xun KangDepartment of Neuro-Oncology, Cancer Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Shoubo YangDepartment of Neuro-Oncology, Cancer Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.ORCID 0000-0003-1126-5461
Wenting XieDepartment of Neuro-Oncology, Cancer Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.ORCID 0000-0003-4387-7577
Yi LinDepartment of Neuro-Oncology, Cancer Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Zhen WuDepartment of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.ORCID 0000-0003-1292-5070
Wenbin LiDepartment of Neuro-Oncology, Cancer Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.ORCID 0000-0001-7638-4395
Feng ChenDepartment of Neuro-Oncology, Cancer Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.ORCID 0000-0003-4819-2518

Funding

Beijing Clinical Key Specialty Project 2-1-2-038The National Key R&D Program of China 2021YFF0901404
6 · The paper itself

Abstract

backgroundSystemic therapeutic options for meningiomas remain limited. Emerging evidence indicates meningiomas harbor an immunosuppressive microenvironment and programmed cell death ligand 1 (PD-L1) expression is significantly upregulated in both tumor cells and tumor-infiltrating immune cells. Here we conducted a single-arm, single-center, open-label, phase 2 clinical trial (NCT04728568) evaluating the programmed cell death receptor-1 (PD-1) inhibitor sintilimab in patients with recurrent/progressive meningiomas following standard surgery and/or radiotherapy.

methodsForty patients (9 grade 1, 18 grade 2, and 13 grade 3) received intravenous sintilimab (200 mg every 3 weeks). According to Response Assessment in Neuro-Oncology for meningioma (RANO-meningioma) criteria, the 6-month progression-free survival rate (PFS-6) was used as the primary endpoint. Secondary endpoints included the 12-month progression-free survival rate (PFS-12), PFS, overall survival (OS), and safety. Peripheral lymphocyte subpopulations, tumor-infiltrating lymphocyte (TIL) densities, and tumor mutational burden (TMB) were evaluated as immunocorrelated biomarkers.

resultsPatients with grade 1 exhibited a PFS-6 of 67.0%, a PFS-12 of 56.0%, and the median PFS was 14 months (95% CI: 0, 31.5). Grade 2/3 patients showed a PFS-6 of 42.0%, a PFS-12 of 19.0%, and the median PFS was 5.0 months (95% CI: 3.46, 6.54). The median OS was 27.0 months (95% CI: 17.26, 36.73) in grade 2/3 patients. The best outcome among all patients was stable disease (SD). Sintilimab was well tolerated without severe adverse events. A patient with a high TMB (13.14 muts/Mb) had a pseudoprogression with sintilimab and maintained stable disease among subsequent treatments. Among 3 patients with matched pre-/post-treatment tumor samples, 2 showed increased PD-1+ T cell expression after sintilimab.

conclusionSintilimab failed to improve PFS-6 in both grade 1 and grade 2/3 recurrent/progressive meningiomas in this single-arm, single-center, and small-sample trial. When evaluating PD-1 inhibitor treatment for recurrent/progressive meningioma patients, who generally have a longer expected survival and high TMB, the use of the Immunotherapy Response Assessment in Neuro-Oncology (iRANO) criteria may be more appropriate to avoid overlooking potential clinical benefits.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalImmune Checkpoint InhibitorsMeningeal NeoplasmsMeningiomaNeoplasm Recurrence, LocalProgrammed Cell Death 1 ReceptorAdultAgedDisease ProgressionFemaleHumansMaleMiddle AgedAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalImmune Checkpoint InhibitorsPDCD1 protein, humanProgrammed Cell Death 1 ReceptorsintilimabmeningiomaPD‐1 inhibitorphase 2 trialprogressiverecurrent

Identifiers

PMID41358608
PMCPMC12683679

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.