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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 380
- 试验地点
- 3
- 主要终点
- Progression free survival
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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);
- •Sign the consent form.
排除标准
- •Distant metastases;
- •Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma;
- •Have or are suffering from other malignant tumors;
- •Participating in other clinical trials;
- •Pregnancy or lactation;
- •Have uncontrolled cardiovascular disease;
- •Severe complication, eg, uncontrolled hypertension;
- •Mental disorder;
- •Drug or alcohol addition;
- •Do not have full capacity for civil acts.
研究组 & 干预措施
Low-dose RT plus ICI
Patients will receive induction chemotherapy plus low-dose radiotherapy and immuce checkpoint inhibitor then followed by concurrent chemoradiotehrapy.
干预措施: Intensity Modulated Radiation Therapy (Radiation)
Low-dose RT plus ICI
Patients will receive induction chemotherapy plus low-dose radiotherapy and immuce checkpoint inhibitor then followed by concurrent chemoradiotehrapy.
干预措施: Chemotherapy (Drug)
Low-dose RT plus ICI
Patients will receive induction chemotherapy plus low-dose radiotherapy and immuce checkpoint inhibitor then followed by concurrent chemoradiotehrapy.
干预措施: Immune checkpoint inhibitor (Biological)
Low-dose RT plus ICI
Patients will receive induction chemotherapy plus low-dose radiotherapy and immuce checkpoint inhibitor then followed by concurrent chemoradiotehrapy.
干预措施: Low-dose radiotherapy (Radiation)
IC+CCRT
Patients will receive induction chemotherapy plus concurrent chemoradiotehrapy.
干预措施: Intensity Modulated Radiation Therapy (Radiation)
IC+CCRT
Patients will receive induction chemotherapy plus concurrent chemoradiotehrapy.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Progression free survival
时间窗: 3 years
From the date of randomization to local or regional recurrence, distant metastasis or any death
次要结局
- Distant metastasis-free survival(3 years)
- Overall survival(3 years)
- Local recurrence-free survival(3 years)
- Regional recurrence-free survival(3 years)
- Acute toxicities(From the start of treatment until 3 months post treatment)
- Late toxicities(3 years post treatment)
- Quality of life score(Through study completion, an average of 3 years)
研究者
Miao Jingjing
Professor
Sun Yat-sen University