Clinical trial · Interventional
Safety and Efficacy Study of Nimotuzumab Plus Neoadjuvant and Concurrent Chemoradiotherapy to Treat Oropharynx and Hypopharynx Cancer
Neoadjuvant and Concurrent Chemoradiotherapy Plus Nimotuzumab in Treating Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Oropharynx and Hypopharynx
NCT01516996CI-TRIAL-00006540unknownPhase 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 purpose of this study is to evaluate the efficiency and safety of adding nimotuzumab to neoadjuvant and concurrent chemoradiotherapy in the treatment of patients with locoregionally advanced squamous cell carcinoma of the oropharynx and hypopharynx.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypopharyngeal Cancer | Malignant Hypopharyngeal Neoplasm | CURATED_EXACT | 0.92 |
| Oropharyngeal Cancer | Malignant Oropharyngeal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel and cisplatin | Drug | — | UNRESOLVED |
| IMRT | Radiation | — | UNRESOLVED |
| Nimotuzumab | Biological | Nimotuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Neoadjuvant and CCRT
- interventionNames
- Drug: docetaxel and cisplatin
- Radiation: IMRT
- type
- EXPERIMENTAL
- label
- Neoadjuvant and CCRT and Nimotuzumab
- interventionNames
- Drug: docetaxel and cisplatin
- Radiation: IMRT
- Biological: Nimotuzumab
Primary outcomes (2)
- measure
- Objective response rate
- timeFrame
- 3 months after all the treatment ending
- description
- Objective Response Rate: Complete response (CR)+ partial response (PR) rates base on RECIST evaluation system.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Informed consent form * Histologically confirmed locally advanced (stages III and IVb), squamous cell carcinoma of the oropharynx and hypopharynx * The tumor mass had to be measurable * Karnofsky performance status ≥70 * Life expectancy estimated than 6 months * Hematologic: WBC≥4×109 /L , plateletes≥100×109 /L, haemoglobin ≥100 g/L; * Hepatic: AST/ALT\<1.5 times upper limit of normal (ULN);serum bilirubin\<1.5 times ULN; * Renal: Creatinine\<1.5 times ULN; Exclusion Criteria: * Known distant metastases * Primary tumor and nodes received surgery(except of biopsy) * Received other anti EGFR monoclonal antibody treatment * Previous chemotherapy or radiotherapy * Participation in other interventional clinical trials within 1 month * Other malignant tumor (except of non-melanoma skin Cancer or carcinoma in situ of cervix) * History of serious allergic or allergy * History of Serious lung or heart disease * Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant
References
Publications (0)
Data not yet available
No reference posted for this study.