NCT07088484尚未招募不适用
Watch-and-Wait Strategy in Patients With Objective Response After Immuno-chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma: A Prospective Multicenter Observational Study
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- 2-year progression-free survival
研究概览
简要总结
The purpose of this study is to compare chemotherapy plus immunotherapy with immunochemotherapy combined subsequent locoregional radiotherapy in recurrent nasopharyngeal carcinoma (NPC), in order to confirm the value of immunotherapy and chemotherapy in recurrent NPC patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years, regardless of sex.
- •Treatment-naïve patients with newly diagnosed metastatic nasopharyngeal carcinoma (NPC).
- •Receiving immunotherapy. (or Treated with immunotherapy)
- •At least one measurable tumor lesion according to RECIST (Response Evaluation Criteria in Solid Tumors) version 1.
- •Adequate organ function.
- •Signed and dated informed consent form indicating that the patient (or legally authorized representative) has been informed of all pertinent aspects of the study.
- •Patients willing and able to comply with scheduled visits and study procedures.
排除标准
- •Patients with distant metastasis of nasopharyngeal carcinoma.
- •Patients who have not received immunotherapy or chemotherapy. (Alternatively: No prior immunotherapy or chemotherapy.)
- •History of another active malignancy within the past 5 years, except for malignancies with a negligible risk of metastasis or death (e.g., expected 5-year overall survival >90%) or malignancies treated with curative intent and with no evidence of disease (e.g., adequately treated carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin, localized prostate cancer treated with curative intent, ductal carcinoma in situ of the breast treated surgically with curative intent).
- •Lack of capacity to provide informed consent.
研究组 & 干预措施
ICI-chemotherapy cohort
All included patients will undergo protocolized ICI-chemotherapy for 4-6 cycles, following by LIMT.
干预措施: ICI-chemotherapy and LIMT (Drug)
结局指标
主要结局
2-year progression-free survival
时间窗: Counting from the start of the treatment for two years.
Defined as the time from the initiation of ICI-chemotherapy to disease progression or death for any reason, whichever occurred first.
次要结局
未报告次要终点
研究者
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