NCT03392545: InSituVac1

Combination of Immunization and Radiotherapy for Malignant Gliomas (InSituVac1)

Status unknown Phase 1 Last updated 11 July 2019

What this trial tests

Phase 1 trial testing Combined immune adjuvants and radiation in High Grade Glioma in 30 participants. Status unknown.

Timeline

1 April 2018

Primary endpoint
1 April 2020

1 June 2020

Quick facts

Lead sponsor	Beijing Tiantan Hospital
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 April 2018
Primary completion	1 April 2020
Estimated completion	1 June 2020
Sites	1 location across China

Drugs / interventions tested

• Combined immune adjuvants and radiation

Conditions studied

• High Grade Glioma — all drugs for High Grade Glioma →
• Glioblastoma — all drugs for Glioblastoma →
• Glioma of Brainstem — all drugs for Glioma of Brainstem →
• Glioma, Malignant — all drugs for Glioma, Malignant →

Sponsor

Beijing Tiantan Hospital

Who can join

Adults 18 to 65, any sex, with High Grade Glioma or Glioblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Glioblastoma multiforme (GBM): An overview of current therapies and mechanisms of resistance.
   Wu W, Klockow JL, Zhang M, Lafortune F, et al · · 2021 · cited 532× · PMID 34302977 · DOI 10.1016/j.phrs.2021.105780
2. Understanding the immunosuppressive microenvironment of glioma: mechanistic insights and clinical perspectives.
   Lin H, Liu C, Hu A, Zhang D, et al · · 2024 · cited 232× · PMID 38720342 · DOI 10.1186/s13045-024-01544-7
3. Harnessing innate immune pathways for therapeutic advancement in cancer.
   Hu A, Sun L, Lin H, Liao Y, et al · · 2024 · cited 150× · PMID 38523155 · DOI 10.1038/s41392-024-01765-9
4. Tumor-Associated Microglia and Macrophages in the Glioblastoma Microenvironment and Their Implications for Therapy.
   Andersen RS, Anand A, Harwood DSL, Kristensen BW. · · 2021 · cited 103× · PMID 34503065 · DOI 10.3390/cancers13174255
5. Toll-like receptors and toll-like receptor-targeted immunotherapy against glioma.
   Xun Y, Yang H, Kaminska B, You H. · · 2021 · cited 96× · PMID 34715891 · DOI 10.1186/s13045-021-01191-2
6. Glioblastoma Immune Landscape and the Potential of New Immunotherapies.
   Daubon T, Hemadou A, Romero Garmendia I, Saleh M. · · 2020 · cited 89× · PMID 33154756 · DOI 10.3389/fimmu.2020.585616
7. Glioblastoma Immunotherapy: A Systematic Review of the Present Strategies and Prospects for Advancements.
   Agosti E, Zeppieri M, De Maria L, Tedeschi C, et al · · 2023 · cited 69× · PMID 37894718 · DOI 10.3390/ijms242015037
8. Radiotherapy in Combination With Cytokine Treatment.
   Palata O, Hradilova Podzimkova N, Nedvedova E, Umprecht A, et al · · 2019 · cited 39× · PMID 31179236 · DOI 10.3389/fonc.2019.00367