Tumor Vaccines for Solid Tumors

Recruiting

• Conditions: Glioma; Solid Tumor
• Interventions: Biological: tumor vaccine; Radiation: Radiotherapy; Drug: Chemotherapy; Procedure: Surgery

• Registration Number: NCT06102837
• Lead Sponsor: Huashan Hospital

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2023-10
• Study Start: 2023-10
• Study First Submitted: 2023-10-22
• Study First Submitted QC: 2023-10-22
• Last Update Submitted: 2023-10-22
• Study First Posted: 2023-10-26
• Last Update Posted: 2023-10-26
• Primary Completion: 2027-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 340

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
glioma patients receiving tumor vaccine	tumor vaccine	-
glioma patients receiving tumor vaccine	Radiotherapy	-
glioma patients receiving tumor vaccine	Chemotherapy	-
glioma patients receiving tumor vaccine	Surgery	-
glioma patients receiving conventional treatment	Radiotherapy	-
glioma patients receiving conventional treatment	Chemotherapy	-
glioma patients receiving conventional treatment	Surgery	-
non-tumor patients	Surgery	-

Primary Outcome Measures

Name	Time	Method
Proteomics	48 months	The issues collected will be used for proteomic sequencing to measure gene expression level in protein
Transcriptomics	48 months	The issues collected will be used for transcriptome sequencing to measure gene expression level.
Immunomics	48 months	The issues collected will be used for TCR/BCR sequencing to measure clonality of lymphocytes
Genomics	48 months	The issues collected will be used for whole genome sequencing or whole exome sequencing to measure gene mutations.
Radiomics	48 months	The features from images will be extracted using algorithm of Deep-learning or Radiomics
IHC analysis	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.

Trial Locations

Locations (1)

Huashan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China