Neoadjuvant vs Adjuvant in Locally Advanced Recurrent NPC

Официальное название

Neoadjuvant-Adjuvant Versus Adjuvant-Only Therapy Combined With Endoscopic Surgery in Advanced Recurrent Nasopharyngeal Carcinoma:A Multicenter Randomized Controlled Trial

Обзор

A multicenter randomized controlled study of surgery combined with neoadjuvant and adjuvant therapy for locally advanced recurrent nasopharyngeal carcinoma in comparison to surgery combined with adjuvant therapy

Подробное описание

Eligible patients are randomized into the control group and the experimental group.

Patients in the experimental group would be administrated 2 courses of neoadjuvant therapy before surgery.After endoscopic surgery, patients would continue to receive 2-4 courses of chemotherapy and 8 courses of immunotherapy.

Patients in the control group would firstly receive endoscopic surgery, followed by chemotherapy and immunotherapy. In total, 4 to 6 courses of chemotherapy and 10 courses of immunotherapy would be administrated.

Вмешательства

• Процедура endoscopic surgery
  The tumor was resected by endoscopic nasopharyngectomy.
• Препарат Neoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapy
  Two courses of Toripalimab Injection and two courses of Toripalimab Injection and Gemcitabine based chemotherapy were given before endoscopic surgery.
• Препарат Adjuvant therapy in experimental group,Toripalimab Injection and Gemcitabine based therapy
  Eight courses of Toripalimab Injection and two to four courses of chemotherapy, or until unacceptable side effects.
• Препарат Adjuvant therapy in control group,Toripalimab Injection and Gemcitabine based therapy
  Ten courses of Toripalimab Injection and four to six courses of chemotherapy,or until unacceptable side effects.

Первичные конечные точки

• EFS [Срок оценки: From randomization and any events(like:progression or toxic effects precluding surgery;inability to resect all gross disease; progression;surgical complications precluding initiation of adjuvant therapy; recurrence;death) up to 1 year]

Вторичные конечные точки (10)

• OS [Срок оценки: Time interval of randomization and death of any cause, up to 5 years]
• DFS [Срок оценки: From randomization to recurrence, metastasis or death, up to 1 year]
• LRFS [Срок оценки: From randomization to local recurrence or death, up to 1 year]
• DMFS [Срок оценки: From randomization to distant metastasis or death, up to 1 year]
• pCR [Срок оценки: Time point of pathological tumor evaluation after sugery, around 2 weeks after sugery]
• ORR [Срок оценки: Time point of imaging evaluation before treatment(or randomization) and before surgery,up to 1 year]
• DCR [Срок оценки: Time point of imaging evaluation before treatment(or randomization) and before surgery,up to 1 year]
• DoR [Срок оценки: First date of response to the date of progression, up to 5 years]
• 1-and 2-year PFS rate [Срок оценки: one- and two-year]
• 1-and 2-year OS rate [Срок оценки: one- and two-year]

Критерии участия

Критерии включения

• Pathologically diagnosed with recurrent nasopharyngeal carcinoma;
• Resectable disease staging rT2 (deep parapharyngeal space, or distance to the internal carotid ≤5mm) or rT3 (excluding the lesions confined to the basal wall of sphenoid sinus), rT4, according to AJCC 8th edition;
• Cervical lymph node metastasis can be controlled locally;
• Aged 18 to 75 years;
• Informed consent forms signed to participate in the trial;
• Without distant metastasis;
• ≥6months from the accomplishment of radical radiation to recurrence
• previously only 1 course of radiotherapy;
• Sufficient organ function;
• ECOG score 0-2 and can tolerate surgery,chemotherapy and immunotherapy.

Критерии исключения

• Participate in other interventional clinical trials;
• Uncontrolled illnesses that interfere with the therapy;
• Suffering from another or multiple malignancy within 5 years (excluding fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ, etc.);
• Any contradiction to surgery;
• With serious autoimmune disease;
• The patient is currently using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive effects (dosage>10mg/day prednisone or other glucocorticoids), and continues to use them within 2 weeks before the first administration;
• 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 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: NCT06235203 · adv-rNPC-RCT-Neo-V1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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