PD-1 Immune Checkpoint Inhibitor Combined With Intensity Modulated Radiation Therapy in the Treatment of Intermediate-risk Nasopharyngeal Carcinoma (T2-3N0 or T1-2N1 and EBV-DNA≤4000 Copy/ml),A Single-arm, Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
To evaluate the safety and efficacy of PD-1 immune checkpoint inhibitor combined with intensity modulated radiation therapy in the treatment of intermediate-risk nasopharyngeal carcinoma (T2-3N0 or T1-2N1 stage and EBV-DNA≤4000 copy/ml).
详细描述
To evaluate the safety and efficacy of PD-1 immune checkpoint inhibitor combined with intensity modulated radiation therapy in the treatment of intermediate-risk nasopharyngeal carcinoma (T2-3N0 or T1-2N1 stage and EBV-DNA≤4000 copy/ml).The primary end point is safety, the secondary end points are short-term efficacy,overall survival (OS), progression-free survival (PFS),Distant metastasis-free survival(DMFS),adverse effects ,quality of life and immune status assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed patients who have not received radiotherapy or chemotherapy
- •Pathologically diagnosed as non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, WHO classification type II or type III).
- •T2-3N0 or T1-2N1 stage and EBV-DNA≤4000 copy/ml (AJCC 8th version) and EBV-DNA≤4000copies/ml
- •Male or non-pregnant female
- •Age between 18 and 65
- •Eastern Cooperative Oncology Group（ECOG）score of 0-
- •Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109/L, platelet (PLT) ≥100×109/L.
- •Liver function: Alanine aminotransferase (ALT), aspartate aminotransferase (AST) <2.0 times the upper limit of normal (ULN); total bilirubin <2.0×ULN.
- •Renal function: creatinine clearance rate ≥60ml/min or serum creatinine <1.5×ULN.
- •The patient has signed the informed consent
排除标准
- •The pathology is keratinizing squamous cell carcinoma (WHO classification is type I).
- •Patients with recurrence and distant metastasis.
- •Patients who have undergone radiotherapy or chemotherapy.
- •Active hepatitis B (HBV-DNA≥500).
- •Patients with autoimmune diseases.
- •Patients with HIV infection.
- •At the same time suffering from other uncontrolled serious diseases.
- •Persons with abnormal functions of the heart, brain, lungs and other important organs.
- •Age> 65 years.
- •pregnancy or breast feeding.
- •Persons with personality or mental illness, without or with limited capacity for civil conduct
研究组 & 干预措施
PD-1 Immune Checkpoint Inhibitor Combined With Intensity Modulated Radiation Therapy
Intensity modulated radiation therapy combined with toripalimab in the treatment of nasopharyngeal carcinoma，once every 2 weeks, 10 cycles in total
干预措施: Intensity modulated radiotherapy (Procedure)
PD-1 Immune Checkpoint Inhibitor Combined With Intensity Modulated Radiation Therapy
Intensity modulated radiation therapy combined with toripalimab in the treatment of nasopharyngeal carcinoma，once every 2 weeks, 10 cycles in total
干预措施: Toripalimab (Drug)
结局指标
主要结局
Adverse events
时间窗: Recent evaluation: 3 months after the end of treatment；Long-term follow-up: 1~5 years after the end of treatment
The severity of adverse events will be determined by the investigator based on CTCAE v 5.0
次要结局
- overall survival (OS)(2 years)
- progression-free survival (PFS)(2 years)
- Distant metastasis-free survival(DMFS)(2 years)
- Response rate (based on RECIST ver1.1)(Recent evaluation: 3 months after the end of treatment；Long-term follow-up: 1~5 years after the end of treatment)
研究者
XIANG YANQUN
professor
Sun Yat-sen University