glioma
Conditions
Interventions
Group A:Combined therapy group:Neoadjuvant PD-1 inhibitor plus DC vaccine
Group B:Monotherapy group:Neoadjuvant PD-1 inhibitor plus Placebo
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years, gender is not limited; 2. ECOG score 0-2 points; 3. The expected survival period is more than 3 months; 4. Relapse after radiotherapy and temozolomide chemotherapy (first or second recurrence); 5. 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); 6. Tumor resection reached total or major resection, confirmed by enhanced MRI within 72 hours after operation; 7. 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; 10. No immune system disease, non-allergic constitution; 11. Be able to receive follow-up and related examinations, and have informed consent signed by the subject or agent.
Exclusion criteria
Exclusion criteria: 1. Confused, mental or psychological disorders, unable or unwilling to cooperate; 2. Patients with obvious diffuse meningeal dissemination or intracerebral dissemination, unable to measure the volume and inoperable; 3. Within 30 days before enrollment, received any other experimental drug treatment or participated in another clinical trial; 4. 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; 5. Active viral or bacterial infection, which cannot be controlled by anti-infective treatment; 6. Those who have experienced severe hypersensitivity reactions after using monoclonal antibodies; 7. Women who are pregnant or breastfeeding; 8. The researchers believe that they are not suitable to participate in this clinical trial due to various reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of treatment-related adverse events;Biomarker for immunotherapy;Immune response before and after immunotherapy; | — |
Countries
China
Contacts
Public ContactZhou Liangfu
Huashan Hospital, Fudan University
Outcome results
None listed