drugset / Trial / NCT05717790
Concurrent and Adjuvant Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation in Nasopharyngeal Carcinoma
Recruiting
288 enrolled
Fourth Affiliated Hospital of Guangxi Medical University
Guilin Medical University, China · collabLiuZhou People's Hospital · collabPeople's Hospital of Baise · collabPeople's Hospital of Guangxi Zhuang Autonomous Region · collabSecond Affiliated Hospital of Guangzhou Medical University · collabThe First People's Hospital of Qinzhou · collabWuzhou Red Cross Hospital · collabYoujiang Medical College for Nationalities · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Nimotuzumab has been granted approval for use in squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal cancer in different countries. This is a multi-center, randomized controlled trial, with the purpose to evaluate the therapeutic efficacy and safety of nimotuzumab combined with induction chemotherapy plus chemoradiation and adjuvant therapy in locoregionally advanced nasopharyngeal carcinoma.
Timeline
- Start
- 2022-12-01
- Primary completion
- 2024-11-30
- Completion
- 2027-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nimotuzumab | Monoclonal antibody | 200 mg | — |
| Background | Cisplatin | Other / unclassified | 100 mg/m2 | — |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | — |