Clinical trial · Interventional
Nimotuzumab Plus Radiotherapy With Concomitant and Adjuvant Temozolomide for Cerebral Glioblastoma
Efficacy and Safety of Nimotuzumab in Addition to Radiotherapy and Temozolomide for Cerebral Glioblastoma
NCT03388372CI-TRIAL-00031020completedPhase 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 study aimed to investigate the clinical benefit contribution and safety of nimotuzumab to the standard combined treatment for patients with newly diagnosed glioblastoma.
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 |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nimotuzumab | Biological | Nimotuzumab | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nimotuzumab plus RT and temozolomide.
- description
- Nimotuzumab, administered once a week intravenously in addition to radiotherapy with concomitant and adjuvant temozolomide (TMZ) after surgery.
- interventionNames
- Biological: Nimotuzumab
- Drug: Temozolomide
- Radiation: Radiotherapy
Primary outcomes (2)
- measure
- Progression-free survival (PFS)
- timeFrame
- 2 years
- description
- PFS will be calculated as the time from surgery to the date of progression-free.
- measure
- Overall survival (OS)
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed, histologically proven single supratentorial GBM (WHO grade 4); * EGFR positive; * \>50% of the gross tumor volume removed by surgery; * Karnofsky performance score (KPS) ≥ 60; * Adequate renal function (creatinine ≤1.5×upper limit of normal \[ULN\] or creatinine clearance ≥ 60 mL/min), hepatic function (total bilirubin ≤1.5×ULN and serum transaminases ≤3×ULN), and hematologic function (white blood cell count ≥ 3,000/uL or absolute neutrophil count ≥ 1,500/uL, platelets ≥ 100,000/uL, and hemoglobin ≥ 10 g/dL). * Tumor tissue was required for central pathology review and re-checking EGFR and MGMT expression status; * An interval of 2 to 6 weeks between surgery and RT was required. Exclusion Criteria: * Negative EGFR expression; * Prior chemotherapy, anti-EGFR therapy, RT, or a history of malignancy in the previous 5 years; * Patients with severe complications or active infection; * Continuous vomiting that could interfere with the oral administration of TMZ; * Pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.