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

NCT05717790 · tracked via the Priya Life Science China tracker

Sponsor

Fourth Affiliated Hospital of Guangxi Medical University

Phase

Not applicable

Started

2022-12-01

Last updated

2023-02-08

Condition(s) studied

Nasopharyngeal Carcinoma by AJCC V8 Stage

Investigational drug(s) / intervention(s)

NimotuzumabGemcitabineCisplatinIntensity-modulated radiotherapy

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 .

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

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.

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

Study 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

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: 1. Age: 18 to 70. 2. Pathological type: non-keratinizing carcinoma (World Health Organization criteria). 3. 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 \[UICC\]. 4. ECOG performance score: 0 to 1. 5. Primary lesions can measurable. 6. Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L. 7. Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and creatinine clearance rate ≥ 50 ml/min (Cockcroft-Gault formula). 8. Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule. Exclusion Criteria: 1. Primary lesions or lymph node have been operated (except of operation for biopsy). 2. Previous Received other anti EGFR monoclonal antibody treatment;Previous chemotherapy or immunization therapy. 3. Other malignant tumor. 4. Participation in other interventional clinical trials within 1 month. 5. History of Serious lung or heart disease. 6. Pregnant or breast-feeding women and women who refused to take contraceptive method. 7. Drug abuse or alcohol addiction. 8. History of serious allergic or allergy. 9. Refused or can't signed informed consent form. 10. Other patients who are considered ineligible for the study by the investigator.

Primary outcome measure(s)

overall survival(OS) — 5 years
Overall survival is measured from day of diagnosis until death due to any cause or the latest known date alive.OS will be measured by the Method of Kaplan and Meier.

Trial sites (9)

Facility	City	Region	Status
People's Hospital of Baise	Baise City	Guangxi	Recruiting
Affiliated Hospital of Youjiang Medical University for Nationalities	Baise City	Guangxi	Recruiting
Guilin Medical University, China	Guilin	Guangxi	Recruiting
Nanxishan Hospital of Guangxi Zhuang Autonomous Region	Guilin	Guangxi	Recruiting
the Fourth Affiliated Hospital of Guangxi Medical University	Liuzhou	Guangxi	Recruiting
Second Affiliated Hospital of Guangzhou Medical University	Nanjing	Guangxi	Recruiting
The First People's Hospital of Qinzhou	Qinzhou	Guangxi	Recruiting
Wuzhou Red Cross Hospital	Wuzhou	Guangxi	Recruiting
Liuzhou People's Hospital	Liuzhou	Other (Non U.s.)	Recruiting

More Fourth Affiliated Hospital of Guangxi Medical University trials in China

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NBI Combined With MRI to Guide CTV Optimization in Eccentric Nasopharyngeal Carcinoma Recruiting

Nimotuzumab Combined With TGP as First-line Therapy in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05717790 on ClinicalTrials.gov ↗ ← All trials in China