Recruiting

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

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What is being tested

Nimotuzumab

+ Gemcitabine

+ Cisplatin

DrugRadiation
Who is being recruted

Nasopharyngeal Carcinoma+11

+ Carcinoma

+ Head and Neck Neoplasms

From 18 to 70 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: December 2022
See protocol details

Summary

Principal SponsorFourth Affiliated Hospital of Guangxi Medical University
Study ContactYing Lu, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2022

Actual date on which the first participant was enrolled.

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 TitleNimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation and Adjuvant Therapy in Locoregionally Advanced Nasopharyngeal Carcinoma
NCT05717790
Principal SponsorFourth Affiliated Hospital of Guangxi Medical University
Study ContactYing Lu, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

288 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Nasopharyngeal CarcinomaCarcinomaHead and Neck NeoplasmsStomatognathic DiseasesNasopharyngeal DiseasesNasopharyngeal NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsPharyngeal DiseasesPharyngeal Neoplasms

Criteria

8 inclusion criteria required to participate
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.
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10 exclusion criteria prevent from participating
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.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Patients will receive induction chemotherapy with gemcitabine (1g/m2, d1 \& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 2 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) will be given. Concurrent nimotuzumab (200mg/w,weekly, 6-7 weeks) and cisplatin (100mg/m2,every 3 weeks for 3cycles )will be administered during IMRT.

Group II

Experimental
Patients will receive induction chemotherapy with nimotuzumab (200mg/w,weekly plus gemcitabine (1g/m2, d1 \& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 2 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) will be given. Concurrent nimotuzumab (200mg/w,weekly, 6-7 weeks) and cisplatin (100mg/m2,every 3 weeks for 3cycles )will be administered during IMRT. After 4-6 weeks of the completion of IMRT, adjuvant nimotuzumab (200mg ) will be given every 3 weeks for 8 cycles.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 9 locations

Recruiting

People's Hospital of Baise

Baise City, ChinaOpen People's Hospital of Baise in Google Maps
Recruiting

Affiliated Hospital of Youjiang Medical University for Nationalities

Baise City, China
Recruiting

Guilin Medical University, China

Guilin, China
Recruiting

Nanxishan Hospital of Guangxi Zhuang Autonomous Region

Guilin, China
Recruiting
9 Study Centers