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

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.

Conditions

• Nasopharyngeal Carcinoma by AJCC V8 Stage

Interventions

DRUG

Nimotuzumab

Drug: Nimotuzumab Experimental: Nimotuzumab arm Induction chemotherapy:Nimotuzumab 200mg will be given weekly for 6 cycles, started on day 1 of induction chemotherapy. Concurrent chemotherapy: Nimotuzumab 200mg/week in concurrent with IMRT. Adjuvant therapy: Nimotuzumab (200mg ) will be given every 3 weeks for 8 cycles. Active Comparator: Control Nimotuzumab 200mg/week in concurrent with IMRT .

DRUG

Gemcitabine

Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 2 cycles

DRUG

Cisplatin

Cisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 2 cycles. Cisplatin as concurrent chemotherapy, 100 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles.

RADIATION

Intensity-modulated radiotherapy

Definitive IMRT of 68-78 Gy, 30-33 fractions, 5 fractions/week, 1 fraction/day

Sponsors & Collaborators

• People's Hospital of Baise

  collaborator UNKNOWN

• Second Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• People's Hospital of Guangxi Zhuang Autonomous Region

  collaborator OTHER

• Guilin Medical University, China

  collaborator OTHER

• LiuZhou People's Hospital

  collaborator OTHER

• The First People's Hospital of Qinzhou

  collaborator UNKNOWN

• Wuzhou Red Cross Hospital

  collaborator OTHER

• Youjiang Medical College for Nationalities

  collaborator OTHER

• Fourth Affiliated Hospital of Guangxi Medical University

  lead OTHER

Principal Investigators

• Ying Lu, MD · The Fourth Affiliated Hospital of Guangxi Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-01

Primary Completion

2024-11-30

Completion

2027-11-30

Countries

• China

Study Locations