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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nimotuzumab group | Experimental | treatment group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nimotuzumab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | defined as the time from randomization (or the initiation of treatment) to death from any cause. | from the initiation of treatment,up to 100 weeks |
| Objective Response Rate | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C501466 | nimotuzumab |
| D000077204 | Temozolomide |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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| Temozolomide | Drug | 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. |
|
| Radiotherapy | Radiation | PTV:60Gy/2Gy/30f,6weeks |
|
| through study completion, an average of 1 year |
| Disease Control Rate | 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 | through study completion, an average of 1 year |
| Adverse Event | 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 | through study completion, an average of 1 year |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |