Observational Study on the Efficacy and Safety of Huaier Granules Compared With Platinum Containing Dual Drug Combination Chemotherapy in Adjuvant Therapy for Resectable Stage II-IIIA Non-small Cell Lung Cancer After Radical Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- 3-year disease-free survival (DFS) rate
研究概览
简要总结
This study is a multicenter, prospective, and observational clinical study aimed at exploring whether the 3-year DFS in the Huaier group is not inferior to the control group receiving standard platinum dual-drug chemotherapy.
详细描述
This study is a small sample observational study, mainly exploring whether the 3-year DFS of the Huaier group is not inferior to the control group receiving standard platinum dual drug chemotherapy. Therefore, this study will conduct a small sample exploratory analysis. It is expected to include 240 non-small cell lung cancer patients who have been diagnosed with stage Ⅱ-ⅢA and are eligible for surgery at selected research centers from April 2023 to July 2025. Among them, 120 patients in the Huaier Granule group refused to undergo adjuvant chemotherapy due to reasons such as intolerance or disagreement, and agreed to receive Huaier Granule monotherapy as an adjuvant treatment; There are 120 patients in the control group, all of whom plan to receive standard chemotherapy as an adjuvant treatment plan (including platinum based dual-drug combination chemotherapy).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old ≤ age ≤ 75, regardless of gender.
- •Confirmed as non-small cell lung cancer by histopathology, with pathological staging of stage Ⅱ-ⅢA.
- •Received radical R0 resection of lung cancer within 2 months before enrollment, and did not receive any postoperative adjuvant therapy or preoperative neoadjuvant therapy.
- •ECOG（Eastern Cooperative Oncology Group）score:0-
- •The patient voluntarily participated in the study, agreed to cooperate with the researcher for data collection, and signed an informed consent form.
排除标准
- •Known to be allergic to the components of Huaier granules or avoid or use Huaier granules with caution (Huaier group).
- •Those who have difficulty swallowing, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, perforation, and other causes of difficulty in taking oral medication.
- •Non-small cell lung cancer patients who plan to receive targeted therapy, immunotherapy, chemotherapy combined with immunotherapy, radiotherapy, synchronous radiotherapy and chemotherapy during the study period.
- •The patient has a history of other new malignant tumors within 5 years.
- •The expected survival time of the patient is less than half a year.
- •Surgical complications that have not recovered or are accompanied by severe infections after radical resection of lung cancer.
- •Pregnant or lactating women or planned pregnancy preparation.
- •The patient has received other traditional Chinese patent medicines and simple preparations with anti-tumor effect in the past one month (including but not limited to compound cantharidin capsule, cinobufagin capsule, Kangai injection, Brucea javanica injection, etc., the specific instructions shall prevail).
- •The patient suffers from severe mental illness or other reasons that the researcher deems unsuitable to participate in this study.
研究组 & 干预措施
Huaier Granule
The subjects voluntarily gave up postoperative adjuvant therapy, including chemotherapy, targeted therapy, immunotherapy, and radiation therapy, and agreed to take Huaier granules.
干预措施: Huaier granule (Drug)
Control
The subjects received standard platinum dual-drug chemotherapy.
干预措施: Control (Other)
结局指标
主要结局
3-year disease-free survival (DFS) rate
时间窗: start of treatment until 3-year follow-up
The proportion of participants who did not experience disease recurrence or death within 3 years after undergoing lung cancer radical surgery.
次要结局
- 1-year or 2-year DFS rate(start of treatment until 1-year or 2-year follow-up)
- 1-year, 2-year or 3-year local recurrence free survival (LRFS) rates(start of treatment until 1-year, 2-year or 3-year follow-up)
- Quality of Life Score (SF-36 Scale)(start of treatment until 3-year follow-up)
- 1-year, 2-year or 3-year overall survival (OS) rate(start of treatment until 1-year, 2-year or 3-year follow-up)
- 1-year, 2-year or 3-year distant metastasis free survival (DMFS) rates(start of treatment until 1-year, 2-year or 3-year follow-up)
- The incidence and severity of adverse events (AE) and severe adverse events (SAE)(start of treatment until 3-year follow-up)
研究者
Hongxu Liu
professor
Liaoning Tumor Hospital & Institute