GliomaNCT06102837
Tumor Vaccines for Solid Tumors
An observational study of Glioma and Solid Tumor, run by Huashan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glioma, Solid Tumor
- What is being tested?
- tumor vaccine, Radiotherapy and Chemotherapy
- Type of treatment
- Vaccines, Surgery or procedure
- How many people
- 340 participants
- Where
- 1 siteChina
- Study dates
- Oct 2023to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing surgery at Huashan Hospital
Who may be able to join
- 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.
Who cannot join
- Patients who meet any of the following criteria will not be included in this study:
- Participants in other clinical trials;
- Pregnant women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Yu Yao, MD, 86-021-5288-9999, yu_yao@fudan.edu.cn
Liangfu Zhou, MD
About this study
Official title: 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.
- Conditions
- Glioma, Solid Tumor
- Being tested
- tumor vaccine, Radiotherapy, Chemotherapy, Surgery
- Keywords
- Glioma, DC vaccine, Database, Biomarker, Artificial intelligence
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tumor vaccineBiological
tumor vaccine produced by our team
RadiotherapyRadiation
conventional treatment in clincial
ChemotherapyDrug
conventional treatment in clinical
SurgeryProcedure or surgery
conventional treatment in clinical
| Study group | Role | What they receive |
|---|---|---|
| glioma patients receiving tumor vaccine | Not described Receives: Biological: tumor vaccine; Radiation: Radiotherapy; Drug: Chemotherapy; Procedure: Surgery | |
| glioma patients receiving conventional treatment | Not described Receives: Radiation: Radiotherapy; Drug: Chemotherapy; Procedure: Surgery | |
| non-tumor patients | Not described Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcriptomics
The issues collected will be used for transcriptome sequencing to measure gene expression level.
Measured: 48 months
Immunomics
The issues collected will be used for TCR/BCR sequencing to measure clonality of lymphocytes
Measured: 48 months
Proteomics
The issues collected will be used for proteomic sequencing to measure gene expression level in protein
Measured: 48 months
Genomics
The issues collected will be used for whole genome sequencing or whole exome sequencing to measure gene mutations.
Measured: 48 months
Radiomics
The features from images will be extracted using algorithm of Deep-learning or Radiomics
Measured: 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.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study startOct 2023 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Yao, MD, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102837
- Sponsor's protocol ID
- KY2023-846
- Other IDs
- 2022YFC3401605, 2022YFC3401600
- Status last verified
- Oct 2023
- First submitted
- 22 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preclinical and Clinical Research on Therapeutic Vaccines for Solid Tumors
- ClinicalTrials.gov ID
- NCT06102837
- Acronym / sponsor ID
- KY2023-846
- Conditions
- Glioma, Solid Tumor
- Keywords
- Glioma, DC vaccine, Database, Biomarker, Artificial intelligence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| glioma patients receiving tumor vaccine | – | Biological: tumor vaccine, Radiation: Radiotherapy, Drug: Chemotherapy, Procedure: Surgery |
| glioma patients receiving conventional treatment | – | Radiation: Radiotherapy, Drug: Chemotherapy, Procedure: Surgery |
| non-tumor patients | – | Procedure: Surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing surgery at Huashan Hospital
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Participants in other clinical trials;
- Pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tumor vaccinetumor vaccine produced by our team | Biological | glioma patients receiving tumor vaccine |
| Radiotherapyconventional treatment in clincial | Radiation | glioma patients receiving conventional treatment, glioma patients receiving tumor vaccine |
| Chemotherapyconventional treatment in clinical | Drug | glioma patients receiving conventional treatment, glioma patients receiving tumor vaccine |
| Surgeryconventional treatment in clinical | Procedure or surgery | glioma patients receiving conventional treatment, glioma patients receiving tumor vaccine, non-tumor patients |
Primary outcome
Transcriptomics
Time frame: 48 months
The issues collected will be used for transcriptome sequencing to measure gene expression level.
Immunomics
Time frame: 48 months
The issues collected will be used for TCR/BCR sequencing to measure clonality of lymphocytes
Proteomics
Time frame: 48 months
The issues collected will be used for proteomic sequencing to measure gene expression level in protein
Genomics
Time frame: 48 months
The issues collected will be used for whole genome sequencing or whole exome sequencing to measure gene mutations.
Radiomics
Time frame: 48 months
The features from images will be extracted using algorithm of Deep-learning or Radiomics
IHC analysis
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma and Solid Tumor, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcriptomics (time frame: 48 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.