Prospective Randomized Trial Comparing Induction Chemotherapy and Immunotherapy Combined Radiotherapy With or Without Concurrent Chemotherapy for Stage III-IVa Nasopharyngeal Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 476
- 试验地点
- 1
- 主要终点
- Failure-free survival
研究概览
简要总结
The purpose of this study is to compare induction chemotherapy (gemcitabine+cisplatin) plus immunotherapy with concurrent chemoradiotherapy (CCRT) or RT alone in patients with stage III-IVa nasopharyngeal carcinoma(NPC), in order to confirm the value of Immunotherapy and concurrent chemotherapy in NPC patients.
详细描述
Patients Patients with stage III-Iva(except T3N0M0) non-keratinizing NPC (UICC/AJCC 8th edition) are randomly assigned to receive immunotherapy and induction chemotherapy plus CCRT or RT alone. Patients in both groups receive Anti-PD-1 Antibody, gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for three cycles before CCRT. The immunotherapy and induction chemotherapy plus CCRT group receive cisplatin 80-100 mg/m² every 3 weeks for 2 cycles, concurrently with intensity-modulated radiotherapy (IMRT). IMRT is given as 2.0-2.30 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor. Our primary endpoint is failure-free survival(FFS). Secondary end points include overall survival (OS), locoregional failure-free survival (LR-FFS), distant failure-free survival (D-FFS) rates and toxic effects. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.
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
- Single (Participant)
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
- •Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type).
- •Tumor staged as III-Iva(except T3N0M0) (according to the 8th AJCC edition).
- •No evidence of distant metastasis (M0).
- •Satisfactory performance status: Karnofsky scale (KPS) ≥
- •Adequate marrow: leucocyte count ≥ 4000/μL, hemoglobin ≥ 90g/L and platelet count ≥ 100000/μL.
- •Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) < 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤ ULN.
- •Adequate renal function: creatinine clearance ≥ 60 ml/min.
- •Patients must be informed of the investigational nature of this study and give written informed consent.
排除标准
- •WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
- •Age > 65 or <
- •Treatment with palliative intent.
- •Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
- •Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
- •History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).
- •Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
- •Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×ULN), and emotional disturbance.
研究组 & 干预措施
The immunotherapy and induction chemotherapy plus RT alone group
Patients receive Anti-PD-1 Antibody, gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for three cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT) alone.
干预措施: without concurrent cisplatin chemotherapy (Drug)
The immunotherapy and induction chemotherapy plus CCRT group
Patients receive Anti-PD-1 Antibody, gemcitabine (1000 mg/m² d1,8) , cisplatin (80mg/m² d1) every 3 weeks for three cycles and cisplatin 80-100 mg/m² every 3 weeks for 2 cycles, concurrently with intensity-modulated radiotherapy (IMRT)
干预措施: with concurrent cisplatin chemotherapy (Drug)
结局指标
主要结局
Failure-free survival
时间窗: 3 years
Failure-free survival rate is calculated from the date of randomization to the date of treatment failure or death from any cause, whichever is first
次要结局
- Distant failure-free survival(3 years)
- Overall survival(3 years)
- Locoregional failure-free survival(3 years)