Clinical trial · Interventional
Induction Chemotherapy With Nimotuzumab in Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)
Phase II Study of Nimotuzumab Plus PF as Induction Chemotherapy in Patients With Locally Advanced HNSCC
NCT00910117CI-TRIAL-00006298completedPhase 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 aim of the study is to evaluate the role of nimotuzumab in the neo-adjuvant setting in patients with locally advanced HNSCC. The hypothesis is that the response would be increased with the combination of nimotuzumab and cisplatin and fluorouracil (PF) regimen.
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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nimotuzumab | Drug | Nimotuzumab | ALIAS |
| PF regimen (cisplatin and 5-FU) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- nimotuzumab
- description
- nimotuzumab plus PF regimen
- interventionNames
- Drug: nimotuzumab
- Drug: PF regimen (cisplatin and 5-FU)
Primary outcomes (1)
- measure
- overall response rate
- timeFrame
- 6 weeks
Secondary outcomes (1)
- measure
- pathologic complete response
- timeFrame
- 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age range 18-70 years old * ECOG performance status 0-1 * Histologically confirmed and potentially resectable locally advanced (T2-4, N0-3, M0) HNSCC * Adequate organ function Exclusion Criteria: * History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * Pregnant or lactating women * Serious uncontrolled diseases and intercurrent infection * Previous serious cardiac disease
References
Publications (0)
Data not yet available
No reference posted for this study.