Combination of Stereotactic Radiosurgery and Enhanced Immunotherapy for Recurrent Glioblastomas(inSituVac2)(CSREIG)

Phase 1

• Conditions: Recurrent Glioblastoma
• Interventions: Combination Product: Combined stereotactic radiosurgery and enhanced immunotherapy

• Registration Number: NCT05131711
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

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.

Detailed Description

Recurrent glioblatoma (rGBM) is an aggressive malignancy with a poor prognosis. There is no standard therapy and survival is less than 9 months. Recently, personalized cancer immunotherapy has shown great promise in treating different types of cancers. However, effective immunotherapies for rGBMs have yet to be established. The last clinical trial (inSituVac1) showed promised results and this study was based on it. We will investigate whether combining stereotactic radiosurgery with intratumoral and systemic administration of enhanced immune adjuvants will improve the treatment outcome of rGBMs. We will use several immune adjuvants that activate innate and adaptive immunity.

Study Timeline

• Status Verified: 2021-11
• Study Start: 2021-11-16
• Study First Submitted: 2021-11-16
• Study First Submitted QC: 2021-11-16
• Last Update Submitted: 2021-11-16
• Study First Posted: 2021-11-23
• Last Update Posted: 2021-11-23
• Primary Completion: 2022-11-16
• Study Completion: 2023-11-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rGBM Group with combined stereotactic radiosurgery and enhanced immunotherapy	Combined stereotactic radiosurgery and enhanced immunotherapy	Patients with rGBMs will receive combined stereotactic radiosurgery and enhanced immunal adjuvants (GM-CSF, Sapylin, MnCl2). The safety and efficacy will be analyzed.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-related Adverse Events	2 years	Adverse events during and after the combined treatment
Progression-free Survival	2 years	Disease progression free survival time after combined treatment

Secondary Outcome Measures

Name	Time	Method
overall survival	2 years	Overall survival time after the combined treatment

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China