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Идёт набор NCT05717790

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

Без фазы С лечением Nasopharyngeal Carcinoma by AJCC V8 Stage

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Nimotuzumab, Gemcitabine, Cisplatin, Intensity-modulated radiotherapy.
Кому может быть актуально
Состояния в реестре: Nasopharyngeal Carcinoma by AJCC V8 Stage. Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

  • Препарат 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 .
  • Препарат Gemcitabine
    Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 2 cycles
  • Препарат 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.
  • Лучевая терапия Intensity-modulated radiotherapy
    Definitive IMRT of 68-78 Gy, 30-33 fractions, 5 fractions/week, 1 fraction/day

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 9 центров
  • 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 — Нанкин
  • The First People's Hospital of Qinzhou — Qinzhou
  • Wuzhou Red Cross Hospital — Wuzhou
  • … и ещё 1 центр

Идентификаторы

NCT: NCT05717790 · ZLK3815405

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗