Concurrent and Adjuvant Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation in Nasopharyngeal Carcinoma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFourth Affiliated Hospital of Guangxi Medical University

About this trial

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.

Eligibility criteria

Qualifiers

Age: 18 to 70.

Pathological type: non-keratinizing carcinoma (World Health Organization criteria).

Diagnosed with LANPC (stage III-IV, except for patients with T3N0)) according to the 8th edition clinical staging system of the American Joint Committee on Cancer [AJCC]/Union for International Cancer Control [UICC].

ECOG performance score: 0 to 1.

Disqualifiers

Primary lesions or lymph node have been operated (except of operation for biopsy).

Previous Received other anti EGFR monoclonal antibody treatment;Previous chemotherapy or immunization therapy.

Other malignant tumor.

Participation in other interventional clinical trials within 1 month.

Trial design

Treatments tested in this trial

  • Nimotuzumab
  • Gemcitabine
  • Cisplatin
  • Intensity-modulated radiotherapy

Treatment groups

288 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Fourth Affiliated Hospital of Guangxi Medical University

Lead sponsor

People's Hospital of Baise

Collaborator

Second Affiliated Hospital of Guangzhou Medical University

Collaborator

People's Hospital of Guangxi Zhuang Autonomous Region

Collaborator

Guilin Medical University, China

Collaborator

LiuZhou People's Hospital

Collaborator

The First People's Hospital of Qinzhou

Collaborator

Wuzhou Red Cross Hospital

Collaborator

Youjiang Medical College for Nationalities

Collaborator