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Nimotuzumab Combined with Intensity Modulated Radiotherapy and Temozolamide Chemotherapy for Primary Glioblastoma

Phase I Clinical Study of nimotuzumab Combined with Intensity Modulated Radiotherapy and Temozolamide Chemotherapy for Primary Glioblastoma

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034068
Enrollment
Unknown
Registered
2020-06-22
Start date
2020-08-19
Completion date
Unknown
Last updated
2020-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma

Interventions

experimental group:Nimotuzumab Combined with Intensity Modulated Radiotherapy and Temozolamide Chemotherapy

Sponsors

The Third Hospital of Peking University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-70 years; 2. Patients with KPS >= 60; 3. GBM was confirmed by histopathology; 4. Patients whose interval from initial diagnosis to admission is less than 4 weeks; 5. According to the gender distribution of GBM, the ratio of female to male was 2:3; 6. Patients with sufficient blood volume (within 14 days before treatment); 7. Neutrophil count >= 1500 / mm3 or leukocyte count >= 2000 / mm3; 8. Platelet >= 100.00/mm3; 9. Hemoglobin >= 10g / dl; 10. Bun 12 weeks; 14. Patients willing to sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who have received brain radiotherapy or DTIC (dacarbazine) or TMZ (temozolomide) chemotherapy; 2. Patients who are known to be allergic to exogenous protein; 3. Patients who have received chemotherapy or EGFR inhibitors; 4. Patients who have received antibody treatment; 5. Patients who did not recover from the acute toxicity of previous treatment; 6. Patients with acute infection requiring antibiotic treatment; 7. Patients who are forbidden to TMZ due to frequent vomiting or other physical conditions; 8. Patients with clinically active hepatorenal or cardiac diseases; 9. Patients who have known other cancers for less than 5 years (excluding cervical carcinoma in situ, basal cell carcinoma and skin squamous cell carcinoma); 10. HIV patients; 11. Pregnant or lactating women; 12. Patients participating in other clinical studies.

Design outcomes

Primary

MeasureTime frame
safety;complication;

Secondary

MeasureTime frame
os;pfs;life quality;

Countries

China

Contacts

Public ContactSuqing Tian

The Third Hospital of Peking University

suqing.tian@bjmu.edu.cn+86 10-822264914

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026