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临床试验/NCT05385926
NCT05385926招募中2 期

A Phase II Study: Safety and Efficacy of Combining Radiation Therapy With Immunotherapy and Chemotherapy in de Novo Metastatic Nasopharyngeal Carcinoma

Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2022年5月5日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

JIN JING

Head of Radiation Oncology

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

研究点 (1)

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