Clinical trial · Interventional
Study of Chemotherapy Combined With Nimotuzumab in Untreated Metastatic Nasopharyngeal Carcinoma
Open-Label, Uncontrolled, Multicenter Phase II Study of Cisplatin and 5-Fu Combined With Nimotuzumab As First-Line Treatment in Patients With Untreated Metastatic Nasopharyngeal Carcinoma
NCT01616849CI-TRIAL-00019165completedPhase 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 an open-label, uncontrolled, multicenter phase II clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of cisplatin and 5-Fu combined with nimotuzumab in patients with untreated metastatic nasopharyngeal carcinoma.
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 |
|---|---|---|---|
| Stage IV Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin and 5-Fu combined with nimotuzumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PF+ Nimotuzumab
- description
- Patients treated with cisplatin and 5-Fu combined with nimotuzumab
- interventionNames
- Drug: cisplatin and 5-Fu combined with nimotuzumab
Primary outcomes (2)
- measure
- Objective response rate
- timeFrame
- study period of 19 Months
- description
- To be determined by measurement of target lesions according to RECIST criteria
- measure
- Progression free survival
- timeFrame
- 19 Months
- description
- Defined as the time in months from first dose of Nimotuzumab until PD is observed or death occurs due to any cause.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic diagnosis of nasopharyngeal carcinoma * Distance metastasis at least 6 months after radical treatment * Not suitable for local treatment, e.g. surgery, TACE * At least one measurable lesion * Estimate survival \>3months * Range from 18～70 years old * PS 0\~1 * WBC count ≥ 4×109/L，Hemoglobin ≥ 100g/L， platelet count ≥ 100×109/L * ALT or AST \< 2.5×ULN、bilirubin \< 1.5×ULN * 0Serum creatinine \< 1.5×ULN Exclusion Criteria: * Central nervous system metastases * Suitable for local treatment * Second malignancy within 5 years * Precious therapy with an investigational agent * Uncontrolled seizure disorder or other serious neurologic disease * ≥ Grade Ш allergic reaction to any drug including in this study * Clinically significant cardiac or respiratory disease * Creatinine clearance \< 30ml/min * Drug or alcohol addition * Do not have full capacity for civil acts * Severe complication, active infection * Concurrent immunotherapy or hormone therapy for other diseases * Pregnancy or lactation
References
Publications (1)
- DERIVEDZhao C, Miao J, Shen G, Li J, Shi M, Zhang N, Hu G, Chen X, Hu X, Wu S, Chen J, Shao X, Wang L, Han F, Mai H, Chua MLK, Xie C. Anti-epidermal growth factor receptor (EGFR) monoclonal antibody combined with cisplatin and 5-fluorouracil in patients with metastatic nasopharyngeal carcinoma after radical radiotherapy: a multicentre, open-label, phase II clinical trial. Ann Oncol. 2019 Apr 1;30(4):637-643. doi: 10.1093/annonc/mdz020. PMID 30689735