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Not yet recruiting NCT07707973

Nimotuzumab Combined With the Stupp Regimen for Postoperative Residual Glioblastoma

Phase II Interventional Glioma, Malignant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: nimotuzumab, Temozolomide, Radiotherapy.
Who it may be relevant to
Registry conditions: Glioma, Malignant. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Single-arm, Phase II Study of Nimotuzumab Combined With the Stupp Regimen for Postoperative Residual Glioblastoma

Overview

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

  • Drug nimotuzumab
    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.
  • Drug Temozolomide
    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.
  • Radiation Radiotherapy
    PTV：60Gy/2Gy/30f，6weeks

Primary outcome measures

  • Progression-Free Survival [Time frame: 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]
Secondary outcome measures (4)
  • Overall Survival [Time frame: from the initiation of treatment，up to 100 weeks]
  • Objective Response Rate [Time frame: through study completion, an average of 1 year]
  • Disease Control Rate [Time frame: through study completion, an average of 1 year]
  • Adverse Event [Time frame: through study completion, an average of 1 year]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07707973 · IST-Nim-GBM-04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗