Adjuvant vs Surgery Only in Early-stage Recurrent NPC

Официальное название

Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial

Обзор

Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial

Подробное описание

This study is an open-label, multicentered, evaluator-blinded , randomized clinical trial.

Patients with early-stage recurrent nasopharyngeal carcinoma were randomized into the control group and the experimental group. Patients in the control group would go through observation and follow-up after recurrent endoscopic surgery, while patients in the experimental group would be treated with adjuvant therapy such as chemotherapy and immunotherapy. A total of 176 subjects are required, with 88 patients in the control group and 88 patients in the experimental group.

Вмешательства

• Препарат Immunotherapy,Toripalimab Injection
  Patients in the experimental group would be implemented with adjuvant Immunotherapy and chemotherapy after endoscopic surgery. Four to six cycles chemotherapy and 10 cycles immunotherapy,or until unacceptable side effects.
• Препарат Chemotherapy,Gemcitabine based regimen
  Patients in the experimental group would be implemented with adjuvant Immunotherapy and chemotherapy after endoscopic surgery. Four to six cycles chemotherapy and 10 cycles immunotherapy,or until unacceptable side effects.

Первичные конечные точки

• DFS [Срок оценки: From date of randomization until the date of first documented recurrence, metastasis or date of death from any cause, whichever came first, assessed up to 24 months]

Вторичные конечные точки (5)

• OS [Срок оценки: From randomization to death of any cause,assessed up to 60 months]
• LRFS [Срок оценки: From randomization to local recurrence or death,assessed up to 24 months]
• DMFS [Срок оценки: From randomization to distant metastasis or death, assessed up to 24 months]
• 1-and 2-year DFS rate [Срок оценки: end of 1st year, end of 2nd year]
• 1-and 2-year OS rate [Срок оценки: end of 1st year, end of 2nd year]

Критерии участия

Критерии включения

• Pathologically diagnosed with recurrent nasopharyngeal carcinoma;
• Stage rT1 or rT2(superficial parapharyngeal space, distance to internal carotid artery >5mm)or rT3 (confined to the bottom wall of the sphenoid sinus),according to AJCC 8th edition;
• Cervical lymph node metastasis can be controlled locally
• Age 18 to 75 years;
• Without distant metastasis;
• Informed consent forms signed;
• ≥6months from the accomplishment of radiation to recurrence
• previously radiotherapy for only 1 course;
• ECOG score 0-2 and can tolerate chemotherapy and immunotherapy
• Sufficient organ function;
• Undergone endoscopic surgery with negative pathological margin;

Критерии исключения

• Participation in other interventional clinical trials;
• Uncontrolled illnesses which will interfere with the ability to undergo therapy;
• Suffering from another or multiple malignancy within 5 years (excluding fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ);
• Any contradiction to immune and chemotherapy;
• With serious autoimmune disease;
• Currently usage of immunosuppressive agents or systemic glucocorticoid therapy (dosage>10mg/day prednisone or other glucocorticoids), and continuing to use them within 2 weeks before the first administration of trial drugs;
• Severe allergic reactions to other monoclonal antibodies;
• History of radioactive particle planting;
• Vaccination with live vaccine within 4 weeks prior to initial administration or possibly during the study period;
• Female patients who are at pregnancy or lactation;
• Other situations that the researchers believe are not suitable for enrollment

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

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 7 центров

• Eye& ENT Hospital, Fudan University — Шанхай
• Fujian Medical University Union Hospital — Фучжоу
• The People's Hospital of Guangxi Zhuang Autonomous Region — Nanning
• Changhai Hospital — Шанхай
• Shanghai Sixth People's Hospital — Шанхай
• Shanghai Zhongshan Hospital — Шанхай
• Shenzhen Second People's Hospital — Шэньчжэнь

Идентификаторы

NCT: NCT06228079 · early-rNPC-RCT-adj

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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