NCT05477979招募中不适用
Cohort Studies of Associations of Psychological Stress With Therapy Efficacy and Prognosis of Lung Cancer, Including Non-small-cell Lung Cancer and Small-cell Lung Cancer With Early and Advanced Staging (STRESS-LUNG)
Second Xiangya Hospital of Central South University1 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2020年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Cohort 1 & 2: Progression-free survival (PFS)
研究概览
简要总结
This is the prospective, observational cohort study (STRESS-LUNG) to explore the associations of psychological stress with progression, efficacy of immune checkpoint inhibitors (ICIs) and prognosis of Lung Cancer. The participants including the patients diagnosed with advanced non-small-cell lung cancer (NSCLC) who received the first-line therapy or neoadjuvant therapy of ICIs; patients diagnosed with advanced small-cell lung cancer (SCLC) receiving the first-line therapy ICIs; patients diagnosed with early small-cell lung cancer (SCLC) receiving surgery.
详细描述
This is the prospective, observational cohort study (STRESS-LUNG) to explore the associations of psychological stress with progression, efficacy of ICIs and prognosis of Lung Cancer. This study will have 4 cohorts
- Cohort 1 (STRESS-LUNG-1): A prospective, observational cohort study to explore the association between psychological stress and the efficacy of first-line treatment of ICIs in advanced NSCLC.
- Cohort 2 (STRESS-LUNG-2): A prospective, observational cohort study to explore the association between psychological stress and the efficacy of first-line treatment of limited-stage and extensive-stage SCLC.
- Cohort 3 (STRESS-LUNG-3): A prospective, observational cohort study to explore the association between psychological stress and the efficacy of neoadjuvant therapy of ICIs in resectable NSCLC.
- Cohort 4 (STRESS-LUNG-4): A prospective, observational cohort study to explore the association of psychological stress with cancer progression, and Prognosis in early-stage NSCLC receiving radical surgery.
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;
- •Histologically confirmed diagnosis of NSCLC;
- •Unresectable locally advanced, metastatic, or recurrent stage ⅢB-Ⅳ based on AJCC TNM staging 8th edition;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- •Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );
- •Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1) ;
- •Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy;
- •Informed and agreed to participate in the study;
排除标准
- •Epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) gene and/or ROS proto-oncogene 1 (ROS1) fusion-positive;
- •Combined with other malignant tumors in the past 3 years;
- •Concurrent acute or chronic psychiatric disorders;
- •Current receiving anti-depressive or anti-anxiety therapy;
- •Previous treatment with other clinical drug trials;
- •Patients with symptomatic brain metastasis;
- •Can't cooperate with psychological scale assessment;
- •Cohort 2 (STRESS-LUNG-2):
- •Age ≥ 18 years；
- •Pathologically diagnosed as small cell lung cancer；
- •Unresectable locally advanced, metastatic, or recurrent stage Ⅲ-Ⅳ based on AJCC TNM staging 8th edition;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- •Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );
- •Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1) ;
- •Receiving PD-1/PD-L1 inhibitors monotherapy or combination with chemotherapy;
- •Informed and agreed to participate in the study;
- •Exclusion Criteria:
- •Combined with other malignant tumors in the past 3 years;
- •Concurrent acute or chronic psychiatric disorders;
- •Current receiving anti-depressive or anti-anxiety therapy;
- •Previous treatment with other clinical drug trials;
- •Patients with symptomatic brain metastasis;
- •Can't cooperate with psychological scale assessment;
- •Cohort 3 (STRESS-LUNG-3):
- •Age ≥18 years ；
- •Pathologically diagnosed as non-small cell lung cancer;
- •Resectable clinical stage IB-IIIB based on AJCC TNM staging 8th edition;
- •At least one measurable lesion can be evaluated according to the RECIST 1.1 standard；
- •Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );
- •Receiving PD-1/PD-L1 inhibitors combined with chemotherapy as neoadjuvant therapy.
- •Cardiopulmonary function can withstand surgery;
- •Informed and agreed to participate in the study;
- •Exclusion Criteria:
- •Epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) gene and/or ROS proto-oncogene 1 (ROS1) fusion-positive;
- •Combined with other malignant tumors in the past 3 years;
- •Concurrent acute or chronic psychiatric disorders;
- •Current receiving anti-depressive or anti-anxiety therapy;
- •Previous treatment with other clinical drug trials;
- •Can't cooperate with psychological scale assessment;
- •Cohort 4 (STRESS-LUNG-4):
- •Age ≥18 years;
- •Pathologically diagnosed as non-small-cell lung cancer；
- •Pathologically stage conformed as early stage of IA-IIIA
- •Available for tumor tissue samples；
- •Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );
- •Receiving radical surgery;
- •Informed and agreed to participate in the study;
- •Exclusion Criteria:
- •Combined with other malignant tumors in the past 3 years;
- •Concurrent acute or chronic psychiatric disorders;
- 另有 3 项未显示
结局指标
主要结局
Cohort 1 & 2: Progression-free survival (PFS)
时间窗: 3 years
Time from the beginning of first-line immunotherapy to the first progression (PD) in patients with lung cancer
Cohort 4: Disease-free survival (DFS)
时间窗: 5 years
The duration between the date after surgery to the date of any recurrence or death firstly
Cohort 3: Pathologic complete response (pCR) rate
时间窗: 3 years
pCR is no viable tumor cells in tumor bed and lymph nodes. The pCR rate is the proportion of patients with a pathologic complete response.
次要结局
- Quality of life(5 years)
- Objective Response Rate (ORR)(2 years)
- Overall survival (OS)(5 years)
研究者
Fang Wu
Professor
Central South University
研究点 (1)
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