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Recruiting NCT05717790

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

No phase Interventional Nasopharyngeal Carcinoma by AJCC V8 Stage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nimotuzumab, Gemcitabine, Cisplatin, Intensity-modulated radiotherapy.
Who it may be relevant to
Registry conditions: Nasopharyngeal Carcinoma by AJCC V8 Stage. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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

Primary outcome measures

  • overall survival(OS) [Time frame: 5 years]
Secondary outcome measures (6)
  • Tumor control probability (TCP) [Time frame: 5 years]
  • Disease-free survival(DFS) [Time frame: 5 years]
  • Locoregional failure-free survival(LRRFS) [Time frame: 5 years]
  • Distant Metastasis-free survival(DMFS) [Time frame: 5 years]
  • Incidence rate of investigator-reported adverse events (AEs) [Time frame: 5 years]
  • Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • 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.
  • Primary lesions can measurable.
  • Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L.
  • Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and creatinine clearance rate ≥ 50 ml/min (Cockcroft-Gault formula).
  • 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

  • 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.
  • History of Serious lung or heart disease.
  • Pregnant or breast-feeding women and women who refused to take contraceptive method.
  • Drug abuse or alcohol addiction.
  • History of serious allergic or allergy.
  • Refused or can't signed informed consent form.
  • Other patients who are considered ineligible for the study by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 9 centers
  • People's Hospital of Baise — Baise City
  • Affiliated Hospital of Youjiang Medical University for Nationalities — Baise City
  • Guilin Medical University, China — Guilin
  • Nanxishan Hospital of Guangxi Zhuang Autonomous Region — Guilin
  • the Fourth Affiliated Hospital of Guangxi Medical University — Liuzhou
  • Second Affiliated Hospital of Guangzhou Medical University — Nanjing
  • The First People's Hospital of Qinzhou — Qinzhou
  • Wuzhou Red Cross Hospital — Wuzhou
  • … and 1 more center

Identifiers

NCT: NCT05717790 · ZLK3815405

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗