Glioma, Malignant
Conditions
Brief summary
This is a prospective, single-arm study. The study population consists of adult patients with a confirmed diagnosis of EGFR-positive high-grade glioma who have radiographic residual tumor following surgical resection. Participants will receive nimotuzumab in combination with the standard Stupp regimen after glioma surgery.
Detailed description
This is a prospective, single-arm study designed to enroll 50 adult patients with a confirmed diagnosis of EGFR-positive high-grade glioma and radiographic residual tumor following surgical resection (primary inclusion criteria). Patients are excluded if they are EGFR-negative; have previously received chemotherapy, anti-EGFR therapy, or radiotherapy; have a history of other malignancies within the past 5 years; present with severe comorbidities or active infections; or experience persistent vomiting that may interfere with the oral administration of temozolomide (TMZ). Following surgery, participants will receive nimotuzumab in combination with the standard Stupp regimen.
Interventions
DRUGnimotuzumab
Nimotuzumab 200 mg will be administered via intravenous infusion once weekly for 6 weeks, followed by 200 mg via intravenous infusion once every 4 weeks for a total of 6 doses.
DRUGTemozolomide
Temozolomide will be administered orally at a dose of 150-200 mg/m²/day for 5 consecutive days. Each cycle lasts 28 days, for a total of 6 cycles.
RADIATIONRadiotherapy
PTV：60Gy/2Gy/30f，6weeks
Sponsors
Tianjin First Central Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 1）Aged 18 to 75 years. * 2）Newly diagnosed glioblastoma consistent with the World Health Organization (WHO) Classification of Tumours of the Central Nervous System, 5th edition. * 3）Epidermal growth factor receptor (EGFR)-positive status confirmed by immunohistochemistry (defined as brown-yellow staining in \>10% of tumor cells). * 4）Partial surgical resection with radiographically measurable residual tumor. * 5）Karnofsky Performance Status (KPS) score ≥ 50% (with KPS decline attributable to the tumor). * 6）Adequate renal function, defined as serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance \> 60 mL/min. * 7）Adequate hepatic function, defined as total bilirubin ≤ 1.5 times the ULN and serum transaminases ≤ 3 times the ULN. * 8）Adequate hematologic function, defined as a white blood cell count ≥ 3,000/μL or an absolute neutrophil count (ANC) ≥ 1,500/μL, platelet count ≥ 100,000/μL, and hemoglobin ≥ 10 g/dL. * 9）An interval of 2 to 6 weeks between surgical resection and the initiation of radiotherapy (RT).
Exclusion criteria
* 1）EGFR-negative status. * 2）Prior treatment with chemotherapy, anti-EGFR therapy, or radiotherapy; or a history of other malignancies within the past 5 years. * 3）Presence of severe comorbidities or active infections, or persistent vomiting that may interfere with the oral administration of temozolomide (TMZ).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival | from the initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, up to 100 weeks | defined as the time from randomization (or the initiation of treatment) to the first documented tumor progression or death from any cause, whichever occurs first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | from the initiation of treatment，up to 100 weeks | defined as the time from randomization (or the initiation of treatment) to death from any cause. |
| Objective Response Rate | through study completion, an average of 1 year | defined as the proportion of patients who achieve a Complete Response (CR) or a Partial Response (PR) out of the total number of evaluable patients |
| Disease Control Rate | through study completion, an average of 1 year | defined as the proportion of patients who achieve a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) out of the total number of evaluable patients |
| Adverse Event | through study completion, an average of 1 year | any unfavorable or unintended medical occurrence in a patient or clinical trial subject administered a pharmaceutical product or device, which does not necessarily have a causal relationship with the treatment |
Outcome results
None listed