Clinical trial NCT05131711: Combination of Stereotactic Radiosurgery and Enhanced Immunotherapy for Recurrent Glioblastomas(inSituVac2)(CSREIG)
Official title: Combination of Stereotactic Radiosurgery and Enhanced Immunotherapy for Recurrent Glioblastomas (inSituVac2)(CSREIG)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Recurrent Glioblastoma
Keywords: recurrent glioblastomas
stereotactic radiosurgery
enhanced immunotherapy
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2021-11-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Treatment-related Adverse Events
timeFrame: 2 years
measure: Progression-free Survival
timeFrame: 2 years
Secondary outcomes:
measure: overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Song Lin, M.D.
role: PRINCIPAL_INVESTIGATOR
References: