Nimotuzumab Combined With the Stupp Regimen for Postoperative Residual Glioblastoma

NCT07707973 | Not Yet Recruiting Phase 2

• 1 other identifier: IST-Nim-GBM-04
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glioma, Malignant

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Overall Survival

  from the initiation of treatment，up to 100 weeks

• Objective Response Rate

  through study completion, an average of 1 year

• Disease Control Rate

  through study completion, an average of 1 year

• Adverse Event

  through study completion, an average of 1 year

Study Arms (1)

nimotuzumab group

EXPERIMENTAL

treatment group

Drug: nimotuzumab; Drug: Temozolomide; Radiation: Radiotherapy

Interventions

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.

nimotuzumab group

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.

nimotuzumab group

Radiotherapy RADIATION

PTV：60Gy/2Gy/30f，6weeks

nimotuzumab group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ）Aged 18 to 75 years.
• ）Newly diagnosed glioblastoma consistent with the World Health Organization (WHO) Classification of Tumours of the Central Nervous System, 5th edition.
• ）Epidermal growth factor receptor (EGFR)-positive status confirmed by immunohistochemistry (defined as brown-yellow staining in \>10% of tumor cells).
• ）Partial surgical resection with radiographically measurable residual tumor.
• ）Karnofsky Performance Status (KPS) score ≥ 50% (with KPS decline attributable to the tumor).
• ）Adequate renal function, defined as serum creatinine ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance \> 60 mL/min.
• ）Adequate hepatic function, defined as total bilirubin ≤ 1.5 times the ULN and serum transaminases ≤ 3 times the ULN.
• ）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.
• ）An interval of 2 to 6 weeks between surgical resection and the initiation of radiotherapy (RT).

You may not qualify if:

• ）EGFR-negative status.
• ）Prior treatment with chemotherapy, anti-EGFR therapy, or radiotherapy; or a history of other malignancies within the past 5 years.
• ）Presence of severe comorbidities or active infections, or persistent vomiting that may interfere with the oral administration of temozolomide (TMZ).

Sponsors & Collaborators

• Tianjin First Central Hospital: lead

MeSH Terms

Conditions

Glioma

Interventions

nimotuzumab; Temozolomide; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 16, 2026
• Study Start: July 3, 2026
• Primary Completion (Estimated): January 3, 2028
• Study Completion (Estimated): June 3, 2029
• Last Updated: July 16, 2026

Record last verified: 2026-07