recurrent and refractory glioblastoma with EGFR alterations
Conditions
Interventions
Control group:For patients sensitive to temozolomide, the standard Stupp protocol for brain glioma is applied, which involves daily oral administration of temozolomide (TMZ) at a dose of 75 mg/m^2 for
if well tolerated, the dose is increased to 200 mg/m^2/day from the second cycle).
Experimental group:Based on the sensitivity to temozolomide, the experimental group was divided into two subgroups: patients who were insensitive to temozolomide were treated with osimertinib (AZD9291
patients who were sensitive to temozolomide were treated with a combination of osimertinib (AZD9291) and temozolomide (TMZ).
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age> =18 and = 60; 6.Expected overall survival > = 3 months; 7.Adequate laboratory parameters: absolute neutrophil count > = 1.5×10?/L; platelet count > = 100×10?/L; liver transaminases < = 3× upper limit of normal (ULN); total bilirubin < = 1.5× ULN; normal renal function (serum creatinine < = 1.7 mg/dL or < = 150 µmol/L); 8.For subjects of reproductive potential, agreement to use effective contraceptive measures throughout the study period; 9.Provision of written informed consent; 10.Stable or tapering dose of corticosteroids within 7 days prior to randomization.
Exclusion criteria
Exclusion criteria: 1.Prior use of any targeted agents targeting the EGFR signaling pathway; 2.Previous treatment with other cytotoxic agents or biologic therapies; 3.Concurrent participation in other interventional clinical trials; 4.Presence of severe hepatic or renal dysfunction, or myelosuppression; 5.Presence of non-hematologic toxicity of CTC grade 4 (excluding alopecia, nausea, and vomiting); 6.Obvious symptoms of elevated intracranial pressure (severe nausea and vomiting, papilledema, etc.); 7.Presence of active infection or other comorbidities that may interfere with treatment evaluation; 8.Pregnant or lactating women, or women planning pregnancy in the near future; 9.History of other malignant tumors; 10.Known hypersensitivity to AZD9291 or temozolomide (TMZ); 11.MMSE score < 10 or presence of severe cognitive impairment; 12.Any other conditions deemed inappropriate for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cranial imaging results; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical symptoms caused by tumors; | — |
Countries
China
Contacts
Public ContactYin Luxin
Xuzhou Medical University Affiliated Hospital
Outcome results
None listed