Clinical trial · Interventional
Combination of Stereotactic Radiosurgery and Enhanced Immunotherapy for Recurrent Glioblastomas(inSituVac2)(CSREIG)
Combination of Stereotactic Radiosurgery and Enhanced Immunotherapy for Recurrent Glioblastomas (inSituVac2)(CSREIG)
- 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 stereotactic radiosurgery and enhanced immunotherapy for recurrent glioblastomas. 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 recurrent glioblastomas, prolonging survivals of patients.
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 |
|---|---|---|---|
| Recurrent Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combined stereotactic radiosurgery and enhanced immunotherapy | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- rGBM Group with combined stereotactic radiosurgery and enhanced immunotherapy
- description
- Patients with rGBMs will receive combined stereotactic radiosurgery and enhanced immunal adjuvants (GM-CSF, Sapylin, MnCl2). The safety and efficacy will be analyzed.
- interventionNames
- Combination Product: Combined stereotactic radiosurgery and enhanced immunotherapy
- type
- NO_INTERVENTION
- label
- rGBM Group with
- description
- After biopsy or tumor resection, this rGBM group was treated with FDA-approved strategies proposed by the MDT group.
Primary outcomes (2)
- measure
- Incidence of Treatment-related Adverse Events
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Histopathologically confirmed rGBM * 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 60 days 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 (0)
Data not yet available