Nimotuzumab in Combination With Chemoradiation for Nasopharyngeal Cancer

Status Active, not recruiting

Clinical Trial 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). Clinical trials are ongoing globally to evaluate nimotuzumab in different indications. Nimotuzumab has been granted approval for use in squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal cancer in different countries. The Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the clinical efficacy, and safety of the combination of Nimotuzumab administered concomitantly with chemotherapy and radiotherapy in patients with advanced nasopharyngeal cancer.

Clinical Trial Description

Patients with advanced nasopharyngeal cancer will be randomized to 2 arms. The patients in experimental arm will be treated with Nimotuzumab which will be used concurrently with radiotherapy and chemotherapy. The chemotherapy regimen were Cisplatin monotherapy. The active comparator arm will be administered chemotherapy and radiotherapy only. The dose and regimen were the same with experiment arm. The patients'hematopoietic , hepatic and renal function tests will be monitored weekly, a physical exam and reassessment of the tumor will be performed at the first and the fourth month, and followup every six months to evaluate the survival index in three years after the study. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01074021
Study type	Interventional
Source	Biotech Pharmaceutical Co., Ltd.
Contact
Status	Active, not recruiting
Phase	Phase 3
Start date	October 2009
Completion date	August 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00370890` - A Trial of Adjuvant Chemotherapy in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy	Phase 3
Recruiting	`NCT04340024` - Discovery of Biomarkers for Intrinsic Radiation Sensitivity in Cancer Patients
Completed	`NCT00697619` - To Evaluate the Efficacy of ZOMETA® in Treatment of Bone Metastases in Patients With Stage IV Nasopharyngeal Cancer	Phase 2
Completed	`NCT00078546` - EBV-Specific CTLs Following CD45 Antibody to Patients With Epstein-Barr Virus (EBV) + Nasopharyngeal Carcinoma (NPC)	Phase 1
Recruiting	`NCT04453826` - Concurrent and Adjuvant PD1 Treatment Combined With Chemo-radiotherapy for High-risk Nasopharyngeal Carcinoma	Phase 3
Active, not recruiting	`NCT03890185` - Docetaxal & Cisplatin vs LDFRT + Docetaxal & Cisplatin in Locally Advanced NPC	Phase 2
Not yet recruiting	`NCT04158414` - Applying PET/MR in Oncology - a Prospective Project	N/A
Completed	`NCT02608073` - A Study of Capecitabine (Xeloda) as First-Line Chemotherapy in Participants With Metastatic Nasopharyngeal Cancer	Phase 2
Completed	`NCT03656250` - Assessment of Treatment Response of Nasopharyngeal Cancer Using Simultaneous 18F-FDG-PET and MRI
Recruiting	`NCT02012699` - Integrated Cancer Repository for Cancer Research
Recruiting	`NCT04476641` - A Study of DC-CIK Immunotherapy in the Treatment of Solid Tumors	Phase 2
Terminated	`NCT03144661` - An Open-Label Safety and Tolerability Study of INCB062079 in Subjects With Advanced Hepatocellular Carcinoma and Other Malignancies	Phase 1
Recruiting	`NCT03003182` - A Study of Nasopharyngeal Carcinoma From Guangdong	N/A
Not yet recruiting	`NCT06349889` - Adebrelimab and Chemoradiotherapy in High-risk Locoregionally Advanced Nasopharyngeal Carcinoma	Phase 2
Completed	`NCT01094405` - Efficacy of Recombinant Epstein-Barr Virus (EBV) Vaccine in Patients With Nasopharyngeal Cancer Who Had Residual EBV DNA Load After Conventional Therapy	Phase 2
Not yet recruiting	`NCT05305131` - Phase II Randomised Trial of Induction Gemcitabine and Cisplatin Versus Gemcitabine, Cisplatin, Pembrolizumab and Bevacizumab (GPPB) in Nasopharyngeal Cancer	Phase 2
Completed	`NCT01800071` - A Phase Ib Trial of MVA-EBNA1/LMP2 Vaccine in Nasopharyngeal Carcinoma	Phase 1
Recruiting	`NCT00304694` - Whole-Body 18F-FDG PET in Induction Chemotherapeutic Response for Advanced NPC Patients	N/A
Recruiting	`NCT05638269` - A Multicentre Study on Features of the Gut Microbiota of Patients With Critical Chronic Diseases in China
Not yet recruiting	`NCT04875611` - Nivolumab in Nasopharyngeal Cancer With Progression During or After Platinum-based Treatment	Phase 2