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Recruiting NCT06102837

Tumor Vaccines for Solid Tumors

Observational Glioma Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: tumor vaccine, Radiotherapy, Chemotherapy, Surgery.
Who it may be relevant to
Registry conditions: Glioma, Solid Tumor. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Preclinical and Clinical Research on Therapeutic Vaccines for Solid Tumors

Overview

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.

Interventions

  • Biological tumor vaccine
    tumor vaccine produced by our team
  • Radiation Radiotherapy
    conventional treatment in clincial
  • Drug Chemotherapy
    conventional treatment in clinical
  • Procedure Surgery
    conventional treatment in clinical

Primary outcome measures

  • Transcriptomics [Time frame: 48 months]
  • Immunomics [Time frame: 48 months]
  • Proteomics [Time frame: 48 months]
  • Genomics [Time frame: 48 months]
  • Radiomics [Time frame: 48 months]
  • IHC analysis [Time frame: 48 months]

Eligibility criteria

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:

  • They were no age limit, male and female;
  • The pathological results of frozen section during operation were gliomas or non-tumor;
  • Tissue (6 mm \* 6 mm) can be used for cell sorting on the basis of not affecting clinical routine diagnosis;
  • Sign informed consent.

Exclusion criteria

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

  • Participants in other clinical trials;
  • Pregnant women.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

China · 1 center
  • Huashan Hospital, Fudan University — Shanghai

Identifiers

NCT: NCT06102837 · KY2023-846 · 2022YFC3401605 · 2022YFC3401600

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗