NCT06243679进行中（未招募）不适用
The Efficacy and Safety of Adjuvant Immunotherapy After Pathological Complete Response Following Neoadjuvant Chemoimmunotherapy in Patients with Resectable NSCLC: a Prospective Real-World Study
Xiangya Hospital of Central South University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- DFS (Disease-Free Survival)
研究概览
简要总结
This is a prospective, observational, multicenter real-world study aiming to investigate the efficacy and safety of NSCLC patients with or without adjuvant immunotherapy who have achieved pathologic complete remission after neoadjuvant immunotherapy.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years ≤ age ≤ 80 years;
- •Histologically or cytologically confirmed NSCLC;
- •Resectable stage IB, II, IIIA, or IIIB (N2) NSCLC according to the staging criteria of the American Joint Committee on Cancer (8th edition);
- •Eastern Cooperative Oncology Group (ECOG) performance status score 0-1 at baseline;
- •With measurable or evaluable diseases according to the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) at baseline;
- •Achieving pathological complete response (pCR) after three cycles of neoadjuvant chemoimmunotherapy, which was assessed by independent pathological examination of surgical specimens;
- •With or without adjuvant immunotherapy postoperatively;
- •Signed and dated written informed consent provided by the patient prior to admission to the study.
排除标准
- •EGFR or ALK aberrations positive;
- •With primary/secondary immunodeficiency diseases or symptomatic interstitial lung diseases;
- •With a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalents) or other immunosuppressive medications within 14 days of study drug administration;
- •With other active malignant tumors currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drugs;
- •Receipt of other investigational drugs during the observation period;
- •Unable to follow the procedures required in the protocol due to any medical, mental or psychological conditions.
研究组 & 干预措施
Adjuvant immunotherapy
干预措施: Immunotherapy (Drug)
结局指标
主要结局
DFS (Disease-Free Survival)
时间窗: Approximately 3 years
Evaluated by investigator based on RECIST1.1
次要结局
- 3-year DFS (disease-free survival) rate(Approximately 3 years)
- OS (Overall Survival)(Approximately 3 years)
- Recurrence and Metastasis Pattern(Approximately 3 years)
- AE (Adverse Event)(Approximately 3 years)
研究者
研究点 (1)
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