Tumor Vaccines for Solid Tumors

Trial Title: Tumor Vaccines for Solid Tumors

NCT ID: NCT06102837

Condition: Glioma
Solid Tumor

Conditions: Official terms:
Glioma

Conditions: Keywords:
Glioma
DC vaccine
Database
Biomarker
Artificial intelligence

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Other

Intervention:

Intervention type: Biological
Intervention name: tumor vaccine
Description: tumor vaccine produced by our team
Arm group label: glioma patients receiving tumor vaccine

Intervention type: Radiation
Intervention name: Radiotherapy
Description: conventional treatment in clincial
Arm group label: glioma patients receiving conventional treatment
Arm group label: glioma patients receiving tumor vaccine

Intervention type: Drug
Intervention name: Chemotherapy
Description: conventional treatment in clinical
Arm group label: glioma patients receiving conventional treatment
Arm group label: glioma patients receiving tumor vaccine

Intervention type: Procedure
Intervention name: Surgery
Description: conventional treatment in clinical
Arm group label: glioma patients receiving conventional treatment
Arm group label: glioma patients receiving tumor vaccine
Arm group label: non-tumor patients

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.

Criteria for eligibility:

Study pop:
Patients undergoing surgery at Huashan Hospital

Sampling method: Non-Probability Sample
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: 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.

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Huashan Hospital, Fudan University

Address:
City: Shanghai
Zip: 200040
Country: China

Status: Recruiting

Contact:
Last name: Yu Yao, MD

Phone: 86-021-5288-9999
Email: yu_yao@fudan.edu.cn

Investigator:
Last name: Liangfu Zhou, MD
Email: Principal Investigator

Start date: October 2023

Completion date: October 2027

Lead sponsor:
Agency: Huashan Hospital
Agency class: Other

Source: Huashan Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06102837