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The Role of B7-H4 in Tumor Vaccine

NCT ID: NCT06156150

Last Updated: 2023-12-05

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

RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-26

Study Completion Date

2026-12-31

Brief Summary

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Glioma patients have poor prognosis because of limited choices of treatment. Therapeutic cancer vaccines have been proved to improve survival in glioma, but resistance is a new challenge for vaccine treatment, and the mechanism is unclear. The applicant found in previous papers that glioma cells induced B7-H4 overexpression in macrophages, and the expression level of B7-H4 is highly correlated with vaccine resistance. Preliminary experiments indicated that B7-H4 protein in macrophages inhibited the expression of ATF3, STAT1 and CXCL9/10, which also resulted in decreased T cell infiltration in glioma model of mouse and was a negative factor of vaccine benefits. Therefore, the applicant hypothesize that B7-H4 inhibits STAT1 transcription by reducing expression of ATF3, resulting in decreased phosphorylated-STAT1 in nucleus, which inhibiting expression and secretion of chemokines 9/10. Thereby, reduced infiltration of T cells in microenvironment will be followed, which ultimately promotes resistance of vaccine treatment in glioma. The follow-up plan of this project will be conducted based on the cells, organoid platform and animal experiments to confirm the role and mechanism of macrophage-derived B7-H4 in secretion of chemokines for T cells and treatment resistance of vaccines. Moreover, the DC vaccine produced by team of the applicant will be used to assess the probability of reversing vaccine resistance when intervening B7-H4 axis. Finally, a model for evaluating clinical benefits from vaccine will be established based on data from clinical trials combining with expression of B7-H4 and clinicopathologic features. This study will provide new evidences for the treatment of cancer vaccines in gliomas.

Detailed Description

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Conditions

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Glioma

Keywords

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glioma treatment resistance immunotherapy cancer vaccine macrophage

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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glioma patients receiving conventional treatment

surgery+radiotherapy+chemotherapy

No interventions assigned to this group

glioma patients with tumor vaccine

surgery+radiotherapy+chemotherapy+tumor vaccine

tumor vaccine

Intervention Type BIOLOGICAL

DC vaccine produced by the Team

Interventions

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tumor vaccine

DC vaccine produced by the Team

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

The patients with glioma in the Department of Neurosurgery of Huashan Hospital Affiliated to Fudan University who meet the following three conditions can be enrolled

1. They were 18-80 years old, male and female;
2. The pathological results of frozen section during operation were gliomas;
3. Tissue (6 mm \* 6 mm) can be used for cell sorting on the basis of not affecting clinical routine diagnosis;
4. Sign informed consent.

Exclusion Criteria

Patients who meet any of the following criteria will not be included in this study:

1. Participants in other clinical trials;
2. Pregnant women.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huashan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yu Yao, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Di Chen

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Di Chen, MD

Role: primary

Other Identifiers

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8230162487

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

KY2023-997

Identifier Type: -

Identifier Source: org_study_id