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

Capital Medical University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Recurrent Glioblastoma

Treatments: Combination Product: Combined stereotactic radiosurgery and enhanced immunotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05131711

B0012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

rGBM Group with combined stereotactic radiosurgery and enhanced immunotherapy

Experimental group

Description:

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

Treatment:

Combination Product: Combined stereotactic radiosurgery and enhanced immunotherapy

rGBM Group with

No Intervention group

Description:

After biopsy or tumor resection, this rGBM group was treated with FDA-approved strategies proposed by the MDT group.