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

NCT ID: NCT05131711

Last Updated: 2021-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-16

Study Completion Date

2023-11-16

Brief Summary

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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

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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.

Conditions

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Recurrent Glioblastoma

Keywords

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recurrent glioblastomas stereotactic radiosurgery enhanced immunotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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rGBM Group with 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.

Group Type EXPERIMENTAL

Combined stereotactic radiosurgery and enhanced immunotherapy

Intervention Type COMBINATION_PRODUCT

Patients will be administrated immunal adjuvants intratumorally and systemically with concurrent stereotactic radiosurgery.

rGBM Group with

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Combined stereotactic radiosurgery and enhanced immunotherapy

Patients will be administrated immunal adjuvants intratumorally and systemically with concurrent stereotactic radiosurgery.

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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stereotactic radiosurgery and GM-CSF, Sapylin, MnCl2

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Song Lin

Neurosurgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Song Lin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

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Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Peijuan Ren, M.D.

Role: CONTACT

Phone: +861059978039

Email: [email protected]

Facility Contacts

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Song Lin, M.D.

Role: primary

Xiaohui Ren, M.D.

Role: backup

Other Identifiers

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B0012

Identifier Type: -

Identifier Source: org_study_id