Glioblastoma
Conditions
Interventions
experimental group:Patients will undergo a combined treatment of radiotherapy and temozolomide (TMZ) for a duration of 6 weeks, with concurrent chemotherapy. After completing this phase, there will be
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1) Pathological examination confirming cases of WHO Grade 4 glioblastoma multiforme (GBM) with a new diagnosis. 2) Age between 18 and 70 years, regardless of gender. 3) Karnofsky Performance Status (KPS) score of =70 before enrollment. 4) Agreement not to receive any treatment for glioblastoma other than radiotherapy, temozolomide, and PERCELLVAC-Sur immunotherapy during the trial. 5) Positive expression of Survivin in immunohistochemistry testing. 6) Female patients must have a negative pregnancy test, and both male and female participants must agree to non-pharmacological contraceptive measures during the trial (from signing the Informed Consent Form [ICF] to 28 days after the last dose). 7) Laboratory tests with the following criteria: a) White blood cell count = 2.0 × 10^3/mm3 (2.0 × 10^9/L) b) Neutrophil count = 1.5 × 10^3/mm3 (1.5 × 10^9/L) c) Platelet count = 100 × 10^3/mm3 (100 × 10^9/L) d) Hemoglobin = 9.0g/dL (90g/L) e) Serum creatinine = 1.5 × the upper limit of normal (ULN) f) Aspartate transaminase (AST) = 3 × ULN g) Alanine transaminase (ALT) = 3 × ULN h) Total bilirubin = 1.5 × ULN i) Coagulation function: International Normalized Ratio (INR) = 1.5 × ULN; Activated Partial Thromboplastin Time (APTT) = 1.5 × ULN 8) Expected survival period of = 14 weeks. 9) Patients or guardians must sign the Informed Consent Form, demonstrating the ability to read and understand the nature of the experimental study.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1) Enhanced MRI within 72 hours after tumor surgery shows residual parts with a diameter exceeding 1cm compared to preoperative remnants. 2) Use of 5-aminolevulinic acid dye during surgery. 3) Failure to complete the prescribed standard 6-week total dose of conformal radiotherapy at 2/3 dose, and cumulative 5 weeks of temozolomide concurrent chemotherapy. 4) Time interval exceeding 50 days from the end of surgery to the start of the 6-week concurrent chemoradiotherapy. 5) Disease progression discovered before the start of treatment after synchronous chemoradiotherapy. 6) Allergic history to the active ingredients or excipients of any investigational drug, including chloride sodium injection containing 10% human serum albumin, penicillin, and ampicillin. 7) Presence of other malignant tumors. 8) Pregnant or lactating women. 9) Corticosteroid (such as dexamethasone) usage exceeding 2mg/day within 30 days before enrollment or during the treatment period, with a single dose interval exceeding 10mg. 10) Need for immunosuppressive agents. 11) Acute infection or unexplained fever: Active viral, bacterial, or fungal infections requiring special treatment (such as antibiotic therapy), or unexplained fever with a temperature exceeding 38?. 12) Concomitant severe or unstable diseases in the heart, lungs, liver, kidneys, and hematopoietic system. a) Positive for human immunodeficiency virus (HIV), syphilis (spirochete of syphilis), hepatitis A virus (HAV), hepatitis B virus (HBV), or hepatitis C virus (HCV), and HTLV-1/2 (human T-cell leukemia virus), cytomegalovirus (CMV) infections. b) Symptomatic congestive heart failure, unstable angina, arrhythmia. c) Acute myocardial infarction within the last 6 months. d) Presence of severe mental illness or neurological damage, poor patient compliance, or lack of autonomy. e) Neurological diseases, diffuse leptomeningeal diseases, and concomitant neurodegenerative diseases. f) Chronic obstructive pulmonary disease exacerbation requiring hospitalization or other respiratory diseases. g) Immunodeficiency or autoimmune diseases, such as systemic lupus erythematosus, polymyositis, insulin-dependent diabetes, etc. 13) Inability or unwillingness to undergo magnetic resonance imaging (MRI) scans. 14) Participation in any clinical trial within the last 3 months. 15) Investigator's judgment that participation in the clinical trial is not appropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose Limiting Toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Overall Survival;Immune effect;DC cell activity and in vivo processes; | — |
Countries
China
Contacts
Public ContactZhou Dabiao
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed