Tumor Vaccines for Solid Tumors

Preclinical and Clinical Research on Therapeutic 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.

Study Overview

• Status: Recruiting
• Conditions: Glioma; Solid Tumor
• Intervention / Treatment: Biological: tumor vaccine; Radiation: Radiotherapy; Drug: Chemotherapy; Procedure: Surgery

• Study Type: Observational
• Enrollment (Estimated): 340

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Huashan Hospital, Fudan University
      • Contact: Yu Yao, MD; Phone Number: 86-021-5288-9999; Email: yu_yao@fudan.edu.cn
      • Principal Investigator: Liangfu Zhou, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgery at Huashan Hospital

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
glioma patients receiving tumor vaccine	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
glioma patients receiving conventional treatment	Radiation: Radiotherapy; conventional treatment in clincial; Drug: Chemotherapy; conventional treatment in clinical; Procedure: Surgery; conventional treatment in clinical
non-tumor patients	Procedure: Surgery; conventional treatment in clinical

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transcriptomics	The issues collected will be used for transcriptome sequencing to measure gene expression level.	48 months
Immunomics	The issues collected will be used for TCR/BCR sequencing to measure clonality of lymphocytes	48 months
Proteomics	The issues collected will be used for proteomic sequencing to measure gene expression level in protein	48 months
Genomics	The issues collected will be used for whole genome sequencing or whole exome sequencing to measure gene mutations.	48 months
Radiomics	The features from images will be extracted using algorithm of Deep-learning or Radiomics	48 months
IHC analysis	Different expression level of proteins (CD3,CD8,B7-H4 et.al) in Gliomas with different grades and molecular subgroups will be measured using immunohistochemical.	48 months

Collaborators and Investigators

• Sponsor: Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: October 22, 2023
• First Submitted That Met QC Criteria: October 22, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 22, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Biomarker; Glioma; Artificial intelligence; Database; DC vaccine
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: KY2023-846; 2022YFC3401605 (Other Grant/Funding Number: Grant from National Key R&D Program of China); 2022YFC3401600 (Other Grant/Funding Number: Grant from National Key R&D Program of China)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No