A Phase II Study: Safety and Efficacy of Combining Radiation Therapy With Immunotherapy and Chemotherapy in de Novo Metastatic Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
Incidences of de novo metastatic nasopharyngeal carcinoma range from 6% to 8% at the time of presentation. For the initial diagnosis of metastatic NPC, PD-1 plus chemotherapy yields a satisfactory outcome with1year PFS of 40%. Previous study demonstrated the benefit of adding radiotherapy to chemotherapy in metastatic NPC, however there is no evidence whether radiotherapy can further improve PFS based on chemotherapy plus PD-1 . The purpose of this study is to evaluate the safety and effectiveness of first-line immunochemotherapy combined with radiotherapy for initial diagnosed metastatic NPC.
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 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age:18-75 years, male or female.
- •Histologically or cytologically confirmed de novo metastatic nasopharyngeal carcinoma.(stage IVb, AJCC 8th)
- •Complete response or partial response after at least 3 cycles (no more than 6 cycles) of chemotherapy combined with immunotherapy
- •Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.
- •Adequate organ function.
- •Patient has given written informed consent.
排除标准
- •Unwilling or unable to provide informed consent
- •Intolerance to radiotherapy or immunotherapy
- •Patients who have head and neck radiotherapy history.
- •previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ
- •women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose
- •in other clinical trials within 30 days
- •Patients with autoimmune disorder, including but not limited to systemic lupus erythematosus or multiple sclerosis;
- •History of primary immunodeficiency
- •History of active tuberculosis, drug-induced interstitial lung disease, or ≥ Grade 2 pulmonitis;
- •Patients with human immunodeficiency virus (HIV) positive;
- •Comorbidities that cannot be controlled by concomitant treatment, including but not limited to: ongoing or active infection, unexplained fever > 38.5°C (subjects with neoplastic fever are judged by the investigator to be included), symptomatic congestive heart failure ≥ Grade 2 according to New York Heart Association (NYHA) functional classification, LVEF (left ventricular ejection fraction) < 50%, hypertension poorly controlled by drugs, unstable angina, arrhythmia, active peptic ulcer disease or gastritis;
- •not suitable for this study judged by researchers
结局指标
主要结局
Progression free survival (PFS)
时间窗: 1year
次要结局
- Objective response rate (ORR)(4-8 weeks)
- Local-regional free survival (LRFS)(1 year)
- Treatment-emergent adverse events(1 year)
- Overall survival (OS)(1year)
- Distant metastasis free survival (DMFS)(1 year)
研究者
JIN JING
Head of Radiation Oncology
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
