PD-1 Antibody Combined With Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients

Официальное название

PD-1 Antibody Combined With Chemoradiotheapy vs. Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients: a Multicenter, Randomised Controlled, Phase III Clinical Trial

Обзор

This is a multicenter, randomized controlled, phase III clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.

Вмешательства

• Препарат PD-1 blocking antibody
  Toripalimab 240mg, D1, every 3 weeks per cycle
• Препарат GP
  Gemcitabine 1.0g/m2, D1 and D8; Cisplatin 80mg/m2, D1, every 3 weeks per cycle, total three cycles
• Лучевая терапия IMRT
  IMRT 60-66Gy, 1.8-2.0Gy/f/day

Первичные конечные точки

• Overall survival [Срок оценки: 3 years]

Вторичные конечные точки (4)

• Progression free survival [Срок оценки: 3 years]
• Short-term effects [Срок оценки: through study completion, an average of 2 months]
• Rate of patients with acute toxicities [Срок оценки: through study completion, an average of 2 months]
• Quality of life: EuroQoL 5 dimension [Срок оценки: through whole study, an average of 3 years]

Критерии участия

Критерии включения

• Diagnosed as local recurrence ± regional recurrence after ≥1 year of radical treatment;
• Not suitable for surgery;
• Newly histologic diagnosis of NPC (WHO II/III);
• Clinical stage rII-IVa (AJCC/UICC 8th);
• ECOG 0-1 point;
• No treatment to rNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
• No contraindications to immunotherapy or radiotherapy;
• Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L;
• Adequate liver function: ALT/AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;
• Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
• Take effective contraceptions during and two months after treatment;
• Patients must be informed of the investigational nature of this study and give written informed consent.

Критерии исключения

• Treated with anti-tumor Chinese medicine treatment;
• Have recurrence with local necrosis;
• Have ≥G3 late toxicities, except for skin, subcutaneous tissue or mucosa;
• Unexplained fever > 38.5 ℃, except for tumor fever;
• Treated with ≥ 5 days antibiotics one month before enrollment;
• Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy); Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA ≥10E4copiers/ml) or hepatitis C virus (HCV) antibody positive; Have previously treated with PD-1 antibody or other immunotherapy for PD-1/PD-L1 pathway;
• Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment;
• Have known allergy to large molecule protein products or any compound of study therapy;
• Pregnant or breastfeeding;
• Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma;
• Have received a live vaccine within 30 days of planned start of study therapy Has psychiatric drug or substance abuse disorders that would interfere with cooperation with the requirements of the trial;
• Any other condition, including mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.

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 · 12 центров

• Sun Yat-sen University Cancer Center — Гуанчжоу
• Peking University Third Hospital — Пекин
• Sichuan Cancer Hospital — Чэнду
• Fujian Province Cancer Hospital — Фучжоу
• Guizhou Cancer Hospital — Guiyang
• Zhejiang Cancer Hospital — Ханчжоу
• Jiangxi Cancer Hospital — Nanchang
• The First Affiliated Hospital of Guangxi Medical University — Nanning
• … и ещё 4 центра

Идентификаторы

NCT: NCT03907826 · rNPC-JS001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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