Clinical trial · Interventional
Nimotuzumab for Recurrent Nasopharyngeal Carcinoma
An Open,Multicenter,Phase II Trial of Intensity Modulated Radiation Therapy Combined With Concurrent Nimotuzumab in Patient With Recurrent Nasopharyngeal Carcinoma
NCT03666221CI-TRIAL-00034793unknownPhase 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)
The study assessed the clinical efficacy, and safety of the combination of Nimotuzumab administered concomitantly with intensity modulated radiation therapy(IMRT) in patients with recurrent nasopharyngeal cancer.
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 |
|---|---|---|---|
| Recurrent Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nimotuzumab | Drug | Nimotuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nimotuzumab plus IMRT
- description
- Patients with recurrent nasopharyngeal carcinoma were given an initial dose of nimotuzumab (200 mg) 7days before receiving concurrent intensity modulated radiation therapy(IMRT) , folowing weekly nimotuzumab (200 mg/week) for totally 8 weeks concurrent with IMRT.
- interventionNames
- Drug: Nimotuzumab
Primary outcomes (2)
- measure
- Tumor response rate after Nimotuzumab concurrent with radiotherapy for recurrent NPC patients
- timeFrame
- Three month after patients subject to the treatment
- description
- The response status (Complete Response + Partial Response) was evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Complete response was defined as disappearance of all target lesions, and Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions, taking as reference the baseline study.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with recurrent tumor in nasopharynx with or without relapse cervical lymph nodes more than 6 months after initial radical treatment. 2. Recurrent nasopharyngeal cancer was confirmed by pathology, marginal recurrence can be diagnosed by imaging examinations. 3. Age 18-70. 4. At least one of the tumor lesions measurable. 5. Functional Status: PS (ECOG) \> 0-1. 6. Normal Bone Marrow Function: White blood cell count \> 4×109/L, hemoglobin \>90g/L, and platelet count \>100×109/L. 7. Normal Hepatic and Renal Function: Alanine Tminotransferase (ALT)/Aspartate Aminotransferase (AST) \< 2.5 times the upper limit of normal (ULN), while total bilirubin (T-Bil) \< 1.5 x ULN and serum creatinine \< 1.5 x ULN. 8. Life expectancy of more than 6 months. 9. All the patients signed the informed consent. 10. Follow up regularly and comply with test requirements. Exclusion Criteria: 1. Patients with recurrent cervical lymph nodes alone. 2. Evidence of distant metastasis 3. The relapse tumor has been treated with chemotherapy, radiotherapy, surgery, immunotherapy and other anti-tumor therapy. 4. Creatinine clearance \< 30ml/min 5. Has received epidermal growth factor targeting therapy. 6. Second malignancy within 5 years(except of Non-melanoma Skin Cancer or carcinoma in situ of cervix). 7. Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc. 8. Active systemic infection. 9. History of Serious lung or heart disease. 10. Drug or alcohol addiction. 11. Persons without capacity for civil conduct or persons with limited capacity for civil conduct. 12. The patient has physical or mental disorders and is believed to be unable to fully or fully understand the possible complications of the study. 13. To receive chronic systemic immunotherapy or hormone therapy other than this study. 14. Women who are pregnant or breast feeding 15. Participation in other drugs clinical trials within 1 month.
References
Publications (0)
Data not yet available
No reference posted for this study.