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NCT Number: NCT06102837

Tumor Vaccines for Solid Tumors

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.

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Key information

Conditions

Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Solid Tumor

Sex eligibility

All sexes

Study type

Observational

Primary location

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location status: Recruiting

Location contact

Liangfu Zhou, MD

PRINCIPAL_INVESTIGATOR

Yu Yao, MD

CONTACT

[email protected]

86-021-5288-9999

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tumor vaccine

Biological

tumor vaccine produced by our team

Radiotherapy

Radiation

conventional treatment in clincial

Chemotherapy

Drug

conventional treatment in clinical

Surgery

Procedure

conventional treatment in clinical

Primary outcomes

  1. Transcriptomics

    Time frame: 48 months

    The issues collected will be used for transcriptome sequencing to measure gene expression level.

  2. Immunomics

    Time frame: 48 months

    The issues collected will be used for TCR/BCR sequencing to measure clonality of lymphocytes

  3. Proteomics

    Time frame: 48 months

    The issues collected will be used for proteomic sequencing to measure gene expression level in protein

  4. Genomics

    Time frame: 48 months

    The issues collected will be used for whole genome sequencing or whole exome sequencing to measure gene mutations.

  5. Radiomics

    Time frame: 48 months

    The features from images will be extracted using algorithm of Deep-learning or Radiomics

  6. IHC analysis

    Time frame: 48 months

    Different expression level of proteins (CD3,CD8,B7-H4 et.al) in Gliomas with different grades and molecular subgroups will be measured using immunohistochemical.

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Official study title

Preclinical and Clinical Research on Therapeutic Vaccines for Solid Tumors

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 26, 2023
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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