Tumor Vaccines for Solid Tumors

• Sponsor: Huashan Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06102837
• Collaborator: (none)
• Enrollment: 340
• Location: 1
• Anticipated Duration (Months): 48
• Patients Per Site Per Month: 7.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glioma; Solid Tumor	Biological: tumor vaccine; Radiation: Radiotherapy; Drug: Chemotherapy; Procedure: Surgery

Study Design

• Study Type: Observational
• Anticipated Enrollment: 340 participants
• Observational Model: Other
• Time Perspective: Other
• Official Title: Preclinical and Clinical Research on Therapeutic Vaccines for Solid Tumors
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Oct 1, 2027
• Anticipated Study Completion Date: Oct 1, 2027

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Transcriptomics [48 months]

   The issues collected will be used for transcriptome sequencing to measure gene expression level.

2. Immunomics [48 months]

   The issues collected will be used for TCR/BCR sequencing to measure clonality of lymphocytes

3. Proteomics [48 months]

   The issues collected will be used for proteomic sequencing to measure gene expression level in protein

4. Genomics [48 months]

   The issues collected will be used for whole genome sequencing or whole exome sequencing to measure gene mutations.

5. Radiomics [48 months]

   The features from images will be extracted using algorithm of Deep-learning or Radiomics

6. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Huashan Hospital, Fudan University	Shanghai	Shanghai	China	200040

Sponsors and Collaborators

• Huashan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yu Yao, MD, Professor, Huashan Hospital
• ClinicalTrials.gov Identifier: NCT06102837
• Other Study ID Numbers: KY2023-846; 2022YFC3401605; 2022YFC3401600
• First Posted: Oct 26, 2023
• Last Update Posted: Oct 26, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yu Yao, MD, Professor, Huashan Hospital: Glioma; DC vaccine; Database; Biomarker; Artificial intelligence
• Additional relevant MeSH terms: Glioma

Study Results

No Results Posted as of Oct 26, 2023