A Clinical Study on the Patterns of Traditional Chinese Medicine Syndromes and Efficacy Differences in Lung Cancer Patients Treated With EGFR-TKI
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3,000
- 试验地点
- 6
- 主要终点
- Disease-Free Survival
研究概览
简要总结
The goal of this observational study is to learn about the relationship between TCM body constitution patterns (called "syndromes") and the effectiveness of EGFR-TKI targeted drugs in patients with lung cancer. Approximately 3000 patients with EGFR-mutant non-small cell lung cancer who are about to start or are already taking EGFR-TKI drugs as part of their regular medical care will be invited to join. Participants will be followed for up to 5 years. During routine clinic visits, researchers will collect their TCM information (such as tongue images and pulse readings) and store small samples of their blood, stool, and tongue coating for future research.
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
- •Pathologically or histologically confirmed non-small cell lung cancer (NSCLC)
- •Age ≥ 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- •Presence of epidermal growth factor receptor (EGFR) mutation confirmed by genetic testing
- •Postoperative Cohort (must meet all of the above and the following):
- •Have undergone curative surgery for lung cancer with R0 resection
- •Are planned to receive or are currently receiving postoperative EGFR-TKI adjuvant therapy within 2 weeks
- •Advanced Cohort (must meet all of the above and the following):
- •Meet stage IIIB-IV criteria according to the 9th edition of the American Joint Committee on Cancer (AJCC), or have stage IIIB or below disease but have refused or are unable to tolerate surgical treatment
- •Have at least one measurable lesion
- •Are planned to receive or are currently receiving first-line EGFR-TKI therapy within 2 weeks
排除标准
- •Unable to comply with baseline assessments
- •Pregnant or breastfeeding women
- •Presence of other uncontrolled malignancies
- •Presence of severe brain diseases or psychiatric disorders that affect the patient's ability to communicate or provide informed consent
- •Individuals without legal capacity, or those with medical or ethical reasons preventing continued participation in the study
- •Refusal to sign the informed consent form
研究组 & 干预措施
Advanced Cohort
Participants in this cohort are patients with stage IIIb-IV non-small cell lung cancer (NSCLC) harboring an EGFR sensitizing mutation, who are receiving or are planned to receive first-line EGFR-TKI therapy within 2 weeks as their first-line treatment.
干预措施: EGFR-TKI (Drug)
Postoperative Cohort
Participants in this cohort are patients who have undergone complete surgical resection (R0) for NSCLC with an EGFR sensitizing mutation and who are receiving or are planned to receive adjuvant EGFR-TKI therapy within 2 weeks as their postoperative treatment.
干预措施: EGFR-TKI (Drug)
结局指标
主要结局
Disease-Free Survival
时间窗: From the date of surgery until the date of first documented tumor recurrence, distant metastasis, or death from any cause, assessed up to 5 years.
From the date of surgery until the date of first documented tumor recurrence, distant metastasis, or death from any cause, whichever occurs first.
Progression-Free Survival
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
Progress free survival defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.
次要结局
- Overall Survival(From the date of randomization until the date of death from any cause, assessed up to 5 years.)
- Disease Control Rate(Through study completion, an average of 3 years.)
- Quality of life evaluation(At the baseline, every 3 months until disease recurrence/progression or the end of the study, assessed up to 3 years.)
- Objective Response Rate(Through study completion, an average of 3 years.)
- Traditional Chinese Medicine Symptom Assessment(At the baseline, every 3 months until disease recurrence/progression or the end of the study, assessed up to 3 years.)