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| Name | Class |
|---|---|
| Duke University | OTHER |
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The study will investigate combined radiotherapy and immunotherapy on malignant gliomas. 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 malignant gliomas, prolonging survivals of patients.
High grade gliomas, such as glioblatoma (GBM) is an aggressive malignancy with a poor prognosis. The current strategy for newly diagnosed GBM patients includes surgery, chemotherapy and radiotherapy. Unfortunately, after the standard treatmetn,the median survival of GBM is only about one year. Once relapsed, 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 high grade gliomas, especially after progression, have yet to be established. Newly diagnosed GBM patients experience recurrence in five or seven months after standard treatment. We will investigate whether combining radiotherapy with intratumoral and systemic administration of immune adjuvants will improve the treatment outcome of high grade gliomas. We will use several immune adjuvants that activate innate and adaptive immunity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined immune adjuvants and radiation | Experimental | Patients with malignant gliomas will receive combined immune adjuvants (GM-CSF, TLR ligands) and radiation. The safety and efficacy will be analyzed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined immune adjuvants and radiation | Combination Product | 24 hours before the radiation, patients will be administrated poly I:C or CAR-T or TCR-T intratumorally and receive granulocyte macrophage colony stimulating factor 5 days after the radiation. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-related Adverse Events | Adverse events during and after the combined treatment | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Disease progression free survival time after combined treatment | 2 years |
| Overall Survival | Overall survival time after the combined treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Song Lin, M.D. | Contact | +861067096509 | linsong2005@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Peijuan Ren, M.D. | Beijing Tiantan Hospital | Study Director |
| Song Lin, M.D. | Beijing Tiantan Hospital | Principal Investigator |
| You-Wen He, M.D. Ph.D. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Recruiting | Beijing | Beijing Municipality | 100050 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38049523 | Derived | Zheng Y, Jiang H, Yang N, Shen S, Huang D, Jia L, Ling J, Xu L, Li M, Yu K, Ren X, Cui Y, Lan X, Lin S, Lin X. Glioma-derived ANXA1 suppresses the immune response to TLR3 ligands by promoting an anti-inflammatory tumor microenvironment. Cell Mol Immunol. 2024 Jan;21(1):47-59. doi: 10.1038/s41423-023-01110-0. Epub 2023 Dec 4. | |
| 34025640 |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D011827 | Radiation |
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| D011070 | Poly I-C |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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|
| 2 years |
| Duke University |
| Principal Investigator |
| Jiang H, Yu K, Cui Y, Ren X, Li M, Yang C, Zhao X, Zhu Q, Lin S. Combination of Immunotherapy and Radiotherapy for Recurrent Malignant Gliomas: Results From a Prospective Study. Front Immunol. 2021 May 7;12:632547. doi: 10.3389/fimmu.2021.632547. eCollection 2021. |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001254 | Astrocytoma |
| D002241 |
| Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D011066 | Poly C |
| D011131 | Polyribonucleotides |
| D011119 | Polynucleotides |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011069 | Poly I |