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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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-12002130
Enrollment
Unknown
Registered
2012-04-13
Start date
2012-05-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Metastatic Nasopharyngeal Carcinoma

Interventions

A:cisplatin+5-Fu+nimotuzumab

Sponsors

Sun Yat-sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Histologic diagnosis of nasopharyngeal carcinoma; 2. Distance metastasis at least 6 months after radical treatment; 3. Not suitable for local treatment, e.g. surgery, TACE; 4. At least one measurable lesion; 5. Estimate survival >3months; 6. Aged 18 to 70 years old; 7. PS 0~1; 8. WBC count >=4*10^9/L, Hemoglobin =100*10^9/L; 9. ALT or AST <2.5*ULN, bilirubin <1.5*ULN; 10. 0Serum creatinine <1.5*ULN.

Exclusion criteria

Exclusion criteria: 1. Central nervous system metastases; 2. Suitable for local treatment; 3. Second malignancy within 5 years; 4. Precious therapy with an investigational agent; 5. Uncontrolled seizure disorder or other serious neurologic disease; 6. >=Grade III allergic reaction to any drug including in this study; 7. Clinically significant cardiac or respiratory disease; 8. Creatinine clearance <30ml/min; 9. Drug or alcohol addition; 10. Do not have full capacity for civil acts; 11. Severe complication, active infection; 12. Concurrent immunotherapy or hormone therapy for other diseases; 13. Pregnancy or lactation.

Design outcomes

Primary

MeasureTime frame
Overall objective rate;Progession-free survival;

Secondary

MeasureTime frame
Duration of response;Time to progression;Overall survival;Toxicity;Quality of life;

Countries

China

Contacts

Public ContactChong Zhao
gzzhaochong@163.com+86 13902206160

Outcome results

None listed

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