Clinical trial · Interventional
Nimotuzumab Combined With the Stupp Regimen for Postoperative Residual Glioblastoma
A Single-arm, Phase II Study of Nimotuzumab Combined With the Stupp Regimen for Postoperative Residual Glioblastoma
NCT07707973CI-TRIAL-00118326Nimotuzumabnot yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma, Malignant | Malignant Glioma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nimotuzumab | Drug | Nimotuzumab | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- nimotuzumab group
- description
- treatment group
- interventionNames
- Drug: nimotuzumab
- Drug: Temozolomide
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Progression-Free Survival
- timeFrame
- 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
- description
- 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 outcomes (4)
- measure
- Overall Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.