Tumor Vaccines for Solid Tumors

Solid Tumor Clinical Trial

Official title:

Preclinical and Clinical Research on Therapeutic Vaccines for Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06102837
• Other study ID #: KY2023-846
• Secondary ID: 2022YFC340160520
• Status: Recruiting
• Start date: October 2023
• Est. completion date: October 2027

Study information

• Verified date: October 2023
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 340
• Est. completion date: October 2027
• Est. primary completion date: October 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioma
• Solid Tumor

Intervention

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

Locations

Country	Name	City	State
China	Huashan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

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