Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05717790
NA

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

Sponsor: Fourth Affiliated Hospital of Guangxi Medical University

View on ClinicalTrials.gov

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.

Official title: Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation and Adjuvant Therapy in Locoregionally Advanced Nasopharyngeal Carcinoma

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

288

Start Date

2022-12-01

Completion Date

2027-11-30

Last Updated

2023-02-08

Healthy Volunteers

No

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

Locations (9)

People's Hospital of Baise

Baise City, Guangxi, China

Affiliated Hospital of Youjiang Medical University for Nationalities

Baise City, Guangxi, China

Guilin Medical University, China

Guilin, Guangxi, China

Nanxishan Hospital of Guangxi Zhuang Autonomous Region

Guilin, Guangxi, China

the Fourth Affiliated Hospital of Guangxi Medical University

Liuchow, Guangxi, China

Second Affiliated Hospital of Guangzhou Medical University

Nanjing, Guangxi, China

The First People's Hospital of Qinzhou

Qinzhou, Guangxi, China

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, China

Liuzhou People's Hospital

Liuchow, Other (Non U.s.), China