Идёт набор NCT05941741

IC Plus Low-dose Radiation Plus Cadonilimab in LANPC

Фаза III С лечением Nasopharyngeal Carcinoma Immune Checkpoint Inhibitor Radiotherapy Chemotherapy

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: Intensity Modulated Radiation Therapy, Chemotherapy, Immune checkpoint inhibitor, Low-dose radiotherapy.
Кому может быть актуально: Состояния в реестре: Nasopharyngeal Carcinoma, Immune Checkpoint Inhibitor, Radiotherapy, Chemotherapy. 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

Induction Chemotherapy Combined With Low-dose Radiation Plus Cadonilimab in Loco-regionally Advanced Nasopharyngeal Carcinoma: a Multi-center, Open-label, Randomized Controlled Phase III Clinical Trial

Обзор

This is a multi-center, open-label, randomized controlled phase III clinical trial in primary diagnosed loco-regionally advanced nasopharyngeal carcinoma (NPC) patients. The purpose of this study is to evaluate the efficacy of induction chemotherapy (IC) combined with low-dose radiation and immune checkpoint inhibitor (ICI) followed by concurrent chemoradiotherapy (CCRT) versus IC+CCRT, and compare the treatment-related adverse events and quality of life in two groups.

Вмешательства

Лучевая терапия Intensity Modulated Radiation Therapy
All target volumes will be outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes are defined in accordance with the International Commission on Radiation Units and Measurements Reports 83. The prescribed dose is 70-72 Gy to PTVp (Planning target volume of the primary tumor), 64-70 Gy to PTVn (Planning target volume of the lymph node), 60- 64Gy to PTV1 (High-risk planning target volume), and 54-58 Gy to PTV2 (Low-risk
Препарат Chemotherapy
Induction chemotherapy: gemcitabine and cisplatin, Q3W, 3 cycles Concurrent chemotherapy: cisplatin, Q3W, 2-3 cycles
Биопрепарат Immune checkpoint inhibitor
Cadonilimab: 10mg/kg, Q3W, 3 cycles
Лучевая терапия Low-dose radiotherapy
Low-dose radiotherapy will be performed to study group, with the use of IMRT.

Первичные конечные точки

Progression free survival [Срок оценки: 3 years]

Вторичные конечные точки (7)

Overall survival [Срок оценки: 3 years]
Local recurrence-free survival [Срок оценки: 3 years]
Regional recurrence-free survival [Срок оценки: 3 years]
Distant metastasis-free survival [Срок оценки: 3 years]
Acute toxicities [Срок оценки: From the start of treatment until 3 months post treatment]
Late toxicities [Срок оценки: 3 years post treatment]
Quality of life score [Срок оценки: Through study completion, an average of 3 years]

Критерии участия

Критерии включения

Newly histologic diagnosis of nasopharyngeal non-keratinizing carcinoma (WHO II/III);
All genders, range from 18-70 years old;
ECOG score 0-1;
Clinical stage T4N1M0 and T1-4N2-3M0 (AJCC/UICC 8th);
Not received radiotherapy, chemotherapy and other anti-tumor treatment (including immunotherapy);
No contraindications to chemotherapy, radiotherapy or immunotherapy;
Adequate organ function: white blood cell count ≥ 4×109/L, neutrophile granulocyte count ≥ 1.5×109/L, hemoglobin ≥ 9g/L, platelet count ≥ 100×109/L; alanine aminotransferase or aspartate aminotransferase < 2.5×upper limit of normal; blood urea nitrogen or creatinine ≤ 1.5×upper limit of normal or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
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