RecruitingNot ApplicableNCT05717790

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

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


Sponsor

Fourth Affiliated Hospital of Guangxi Medical University

Enrollment

288 participants

Start Date

Dec 1, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding the targeted antibody drug nimotuzumab (which blocks a growth signal called EGFR) to the standard treatment of induction chemotherapy plus chemoradiation improves outcomes for patients with locally advanced nasopharyngeal cancer (cancer at the back of the nasal cavity). **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with locally advanced nasopharyngeal carcinoma (stage III-IV, non-keratinizing type) - Your general health is good (ECOG score 0-1) - Your blood counts and organ function are within acceptable ranges - The primary tumor site can be measured **You may NOT be eligible if...** - You have had prior surgery to the primary tumor (other than a diagnostic biopsy), prior chemotherapy, or prior anti-EGFR treatment - You have another active cancer - You have serious heart or lung disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNimotuzumab

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 .

DRUGGemcitabine

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

DRUGCisplatin

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.

RADIATIONIntensity-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

Liuzhou, 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

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

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NCT05717790


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