Skip to content

Preclinical and clinical research on therapeutic vaccines for solid tumors

Preclinical and clinical research on therapeutic vaccines for solid tumors (glioma)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300077272
Enrollment
Unknown
Registered
2023-11-02
Start date
2023-11-03
Completion date
Unknown
Last updated
2023-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

glioma

Interventions

glioma patients receiving tumor vaccine:surgery+conventional treatment(radiotherapy, chemotherapy, et.al)+tumor vaccine
glioma patients receiving conventional treatment:surgery+conventional treatment(radiotherapy, chemotherapy, et.al)
non-tumor patients:surgery

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 100 Years

Inclusion criteria

Inclusion criteria: Samples and clinical information from glioma patients (receive DC vaccine) will be collected prospectively All patients in Neurosurgery Department of Huashan Hospital Affiliated to Fudan University can be enrolled if they meet all of the following criteria: ?Aged 18 to 70 years, gender is not limited; ?ECOG score 0-2 points; ?The expected survival period is more than 3 months; ? Relapse after radiotherapy and temozolomide chemotherapy (first or second recurrence); ? This histopathology or molecular pathology is consistent with recurrent grade 4 gliomas (refer to "WHO (2021) Classification of Tumors of the Central Nervous System" and cIMPACT-NOW Update); ?Tumor resection reached total or major resection, confirmed by enhanced MRI within 72 hours after operation; ?Within 7 days before the administration of DC cells or PD-1 antibody, the dose of corticosteroids should be stable or gradually reduced (dose=110g/L (no blood transfusion within 14 days); absolute neutrophil count (ANC) >=1.0x10^9/L; platelet (PLT) >=100x10^9 /L; (2) Biochemical tests: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =60ml/min; (3) Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) = 50%, normal electrocardiogram; (5) The chest X-ray is normal; (6) Thyroid function indicators: Thyroid-stimulating hormone (TSH) and free thyroxine (FT3/FT4) are in the normal range; ? No immune system disease, non-allergic constitution; ? Be able to receive follow-up and related examinations, and have informed consent signed by the subject or agent. Samples and clinical information from glioma patients will be collected prospectively All patients in Neurosurgery Department of Huashan Hospital Affiliated to Fudan University can be enrolled if they meet all of the following criteria: ?No limit of years, male or female; ?Image diagnosis is glioma; ?Surgery is required; ?The pathology confirmed with glioma; ?On the basis of ensuring that routine clinical diagnosis and treatment is not affected, a certain amount of fresh biological samples can be used for research; ?Sign informed consent voluntarily. Samples and clinical information from non-tumor patients will be collected prospectively All patients in Neurosurgery Department of Huashan Hospital Affiliated to Fudan University can be enrolled if they meet all of the following criteria: ?No limit of years, male or female; ?Image diagnosis is hemorrhagic stroke/ischemic stroke/traumatic brain injury; ?Surgery is required; ?On the basis of ensuring that routine clinical diagnosis and treatment is not affected, a certain amount of fresh biological samples can be used for research; ?Sign informed consent voluntarily. Samples and clinical information of glioma patients will be collected retrospectively ?No limit of years, male or femal

Exclusion criteria

Exclusion criteria: Samples and clinical information from glioma patients (receive DC vaccine) will be collected prospectively Patients who meet any of the following criteria will not be enrolled in this study: ?Confused, mental or psychological disorders, unable or unwilling to cooperate; ?Patients with obvious diffuse meningeal dissemination or intracerebral dissemination, unable to measure the volume and inoperable; ?Within 30 days before enrollment, received any other experimental drug treatment or participated in another clinical trial; ?Patients suffering from autoimmune diseases, organ transplantation and other immune-related diseases under treatment, or patients who have been using immunosuppressive drugs such as glucocorticoids for a long time; ? Active viral or bacterial infection, which cannot be controlled by anti-infective treatment; ?Those who have experienced severe hypersensitivity reactions after using monoclonal antibodies; ?Women who are pregnant or breastfeeding; ? The researchers believe that they are not suitable to participate in this clinical trial due to various reasons. Samples and clinical information from glioma patients will be collected prospectively Patients who meet any of the following criteria will not be enrolled in this study: ?The frozen pathology was not consistent with glioma/hemorrhagic stroke/ischemic stroke/traumatic brain injury; ?After removing the samples required for normal diagnosis and treatment, the remaining sample size is not enough for research; ?Patients are unwilling to join the study. Samples and clinical information from non-tumor patients will be collected prospectively Patients who meet any of the following criteria will not be enrolled in this study: ?After removing the samples required for normal diagnosis and treatment, the remaining sample size is not enough for research; ?Patients are unwilling to join the study. Samples and clinical information of glioma patients will be collected retrospectively Patients who meet any of the following criteria will not be enrolled in this study: ?Wax blocks stored for too long and moldy; ?Unwilling to participate in the study.

Design outcomes

Primary

MeasureTime frame
Transcriptomics;Immunomics;Proteomics;Genomics;Radiomics;

Countries

China

Contacts

Public ContactYu Yao

Huashan Hospital, Fudan University

1272807893@qq.com+86 183 1708 0153

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026