Tumor Vaccines for Solid Tumors

NCT ID: NCT06102837

Last Updated: 2023-10-26

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

340 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-31

Study Completion Date

2027-10-31

Brief Summary

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Glioma is the most common primary malignant intracranial tumor, characterized by limited clinical treatment options and extremely poor prognosis. There is an urgent need for the development of new technologies and clinical practice. With the advancement of immunotherapy, tumor therapeutic vaccines have emerged as a hot topic in the field of solid tumor immunotherapy. Several clinical trials have confirmed that tumor vaccines can improve the prognosis of glioma patients. Vaccines are the first systemic treatment technology in nearly 30 years that can simultaneously extend the overall survival of patients with newly diagnosed glioblastoma and recurrent glioblastoma in Phase III clinical trials. This novel approach holds significant clinical value and brings hope to large number of patients. Our team has previously developed a dendritic cell (DC) vaccine for glioma, and the phase II clinical trial has demonstrated that it can extend the prognosis of glioma patients. However, several patients benefit less from vaccine therapy. Therefore, the identification of molecular mechanisms that render patients unresponsive to vaccine treatment is critical to improving vaccine efficacy. This project aims to collect various types of clinical samples from patients, including glioma patients receiving tumor vaccine treatment, glioma patients receiving conventional clinical treatment without tumor vaccine, and non-tumor patients (hemorrhagic stroke, ischemic stroke, and traumatic brain injury). High-throughput sequencing techniques will be used to establish an immune microenvironment database, followed by bioinformatics analysis and molecular biology experiments to uncover the molecular mechanisms influencing vaccine efficacy. Artificial intelligence and deep learning technologies will be employed to extract molecular mechanisms related information from radiology images and pathology images. Ultimately, the project seeks to establish an integrated diagnostic and treatment model that combines imaging, pathology, and omics data to advance the clinical application of vaccines.

Detailed Description

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Conditions

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Glioma Solid Tumor

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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glioma patients receiving tumor vaccine

tumor vaccine

Intervention Type BIOLOGICAL

tumor vaccine produced by our team

Radiotherapy

Intervention Type RADIATION

conventional treatment in clincial

Chemotherapy

Intervention Type DRUG

conventional treatment in clinical

Surgery

Intervention Type PROCEDURE

conventional treatment in clinical

glioma patients receiving conventional treatment

Radiotherapy

Intervention Type RADIATION

conventional treatment in clincial

Chemotherapy

Intervention Type DRUG

conventional treatment in clinical

Surgery

Intervention Type PROCEDURE

conventional treatment in clinical

non-tumor patients

Surgery

Intervention Type PROCEDURE

conventional treatment in clinical

Interventions

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tumor vaccine

tumor vaccine produced by our team

Intervention Type BIOLOGICAL

Radiotherapy

conventional treatment in clincial

Intervention Type RADIATION

Chemotherapy

conventional treatment in clinical

Intervention Type DRUG

Surgery

conventional treatment in clinical

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

The patients with glioma patients/non-tumor patients (hemorrhagic stroke, ischemic stroke, and traumatic brain injury) in the Department of Neurosurgery of Huashan Hospital Affiliated to Fudan University who meet the following three conditions can be enrolled:

1. They were no age limit, male and female;
2. The pathological results of frozen section during operation were gliomas or non-tumor;
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.
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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Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Yu Yao, MD

Role: primary

86-021-5288-9999

Other Identifiers

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2022YFC3401605

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2022YFC3401600

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

KY2023-846

Identifier Type: -

Identifier Source: org_study_id

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