Clinical trial · Interventional
Combination of Immunization and Radiotherapy for Malignant Gliomas (InSituVac1)
- 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)
The study will investigate combined radiotherapy and immunotherapy on malignant gliomas. Immune adjuvants will be injected intratumorally and systemically to induce antitumor-specific immunity after radiation induced immunological tumor cell death (ICD). With radiation, tumor cells release tumor antigens that are captured by antigen presenting dendritic cells. Immune adjuvants promote the presentation of tumor antigens and the priming of antitumor T lymphocytes. The combined treatment induces and amplifies the specific antitumor immunity in patients with malignant gliomas, prolonging survivals of patients.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Glioma, Malignant | Malignant Glioma | ALIAS | 0.90 |
| Glioma of Brainstem | Brain Stem Glioma | ALIAS | 0.90 |
| High Grade Glioma | High-Grade Glioma, NOS | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combined immune adjuvants and radiation | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combined immune adjuvants and radiation
- description
- Patients with malignant gliomas will receive combined immune adjuvants (GM-CSF, TLR ligands) and radiation. The safety and efficacy will be analyzed.
- interventionNames
- Combination Product: Combined immune adjuvants and radiation
Primary outcomes (1)
- measure
- Incidence of Treatment-related Adverse Events
- timeFrame
- 2 years
- description
- Adverse events during and after the combined treatment
Secondary outcomes (2)
- measure
- Progression-free Survival
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histopathologically confirmed glioma 2. Age18-65 3. Participants had undergone maximal surgical resection 4. Amount of dexamethasone was not more than 2mg/ days 5. Ability and willingness to sign informed consent 6. Karnofsky Performance Score of 70 or more 7. Normal liver and kidney function 8. Not accepted other treatment plan during the immunotherapy Exclusion Criteria: 1. Not conforming to the standard 2. Systemic illness or medical condition may pose additional risk,including cardiac, incompensated renal or liver function abnormalities;inflammatory and immune system diseases of rheumatic arthritis 3. Received other drugs for glioma therapy 60days before participated 4. Allergy to immune adjuvant 5. Nervous system disease and diffuse leptomeningeal disease 6. Amount of dexamethasone was more than 2mg/days during the immunotherapy 7. Pregnant or lactation
References
Publications (2)
- DERIVEDZheng Y, Jiang H, Yang N, Shen S, Huang D, Jia L, Ling J, Xu L, Li M, Yu K, Ren X, Cui Y, Lan X, Lin S, Lin X. Glioma-derived ANXA1 suppresses the immune response to TLR3 ligands by promoting an anti-inflammatory tumor microenvironment. Cell Mol Immunol. 2024 Jan;21(1):47-59. doi: 10.1038/s41423-023-01110-0. Epub 2023 Dec 4. PMID 38049523
- DERIVEDJiang H, Yu K, Cui Y, Ren X, Li M, Yang C, Zhao X, Zhu Q, Lin S. Combination of Immunotherapy and Radiotherapy for Recurrent Malignant Gliomas: Results From a Prospective Study. Front Immunol. 2021 May 7;12:632547. doi: 10.3389/fimmu.2021.632547. eCollection 2021. PMID 34025640