Tumor Vaccines for Solid Tumors
Preclinical and Clinical Research on Therapeutic Vaccines for Solid Tumors
3 other identifiers
observational
340
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2023
CompletedFirst Submitted
Initial submission to the registry
October 22, 2023
CompletedFirst Posted
Study publicly available on registry
October 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
October 26, 2023
October 1, 2023
4 years
October 22, 2023
October 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
Study Arms (3)
glioma patients receiving tumor vaccine
glioma patients receiving conventional treatment
non-tumor patients
Interventions
conventional treatment in clincial
conventional treatment in clinical
conventional treatment in clinical
Eligibility Criteria
Patients undergoing surgery at Huashan Hospital
You may qualify if:
- 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.
You may not qualify if:
- Patients who meet any of the following criteria will not be included in this study:
- Participants in other clinical trials;
- Pregnant women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huashan Hospitallead
Study Sites (1)
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 22, 2023
First Posted
October 26, 2023
Study Start
October 1, 2023
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
October 26, 2023
Record last verified: 2023-10