jRCT1041260107招募中不适用
A prospective multicenter single-arm study evaluating the efficacy and safety of adjuvant carboplatin plus nanoparticle albumin-bound paclitaxel in patients with non-small cell lung cancer complicated by interstitial lung disease
未提供0 个研究点目标入组 28 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
入排标准
- 年龄范围
- 18age 0month 0week old over 至 80age 0month 0week old under（—）
- 性别
- All
入选标准
- •(1) Patients with pathologically confirmed stage IIA-IIIB non-small cell lung cancer (NSCLC) according to the 9th edition of the General Rules for Clinical and Pathological Record of Lung Cancer.
- •(2) Patients who have undergone lobectomy or segmentectomy.
- •(3) Patients who were diagnosed, based on preoperative chest CT findings reviewed at a multidisciplinary conference involving pulmonologists and radiologists, as having one of the following imaging patterns, and who were considered unsuitable for postoperative adjuvant chemotherapy with cisplatin plus vinorelbine:
- •Usual interstitial pneumonia (UIP) pattern
- •Probable UIP pattern
- •Indeterminate for UIP pattern
- •(4) Patients who have undergone complete resection of the pulmonary lesion, including metastatic lymph nodes.
- •(5) Patients aged 18 to 80 years at the time of registration.
- •(6) Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at the time of registration.
- •(7) Patients who are able to initiate the study treatment within 8 weeks after surgery.
- •(8) Patients who have provided written informed consent to participate in this study.
排除标准
- •(1) Patients with a history of acute exacerbation of interstitial pneumonia.
- •(2) Patients who meet any of the following criteria on preoperative pulmonary function testing:
- •Percent diffusing capacity of the lung for carbon monoxide (%DLCO) less than 55%
- •Percent forced vital capacity (%FVC) less than 75%
- •(3) Patients who meet any of the following laboratory criteria at the time of registration:
- •Neutrophil count 1,500/mm3 or lower
- •Platelet count 100,000/mm3 or lower
- •(4) Patients receiving continuous systemic administration of corticosteroids or other immunosuppressive agents at the time of registration.
- •(5) Patients who have received neoadjuvant therapy (chemotherapy, radiotherapy, or immune checkpoint inhibitors).
- •(6) Patients with a history of allergic reactions to platinum-based agents, paclitaxel, or albumin preparations
- •(7) Patients who are scheduled to receive atezolizumab following postoperative chemotherapy.
- •(8) Patients with severe comorbidities (including but not limited to persistent diarrhea, active infection, hepatic dysfunction, renal dysfunction, poorly controlled diabetes mellitus, history of myocardial infarction within 6 months prior to registration or unstable angina, cor pulmonale, pulmonary hypertension) or varicella infection.
- •(9) Women who are pregnant, breastfeeding, of childbearing potential with a possibility of pregnancy, or intending to become pregnant.
- •(10) Patients who are deemed inappropriate for participation in this study by the principal investigator or sub-investigator.
研究者
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