Huaier Granule for Prevention of Recurrence and Metastasis of Stage II and III NSCLC After Postoperative Adjuvant Chemotherapy: A Multicenter Randomized, Double-blind, Placebo-controlled Clinical Trial, Along With a Registration Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- disease-free survival
研究概览
简要总结
This study including two parts，one part is a randomized clinical trial design，another part is a registration study.
详细描述
This study include a multicenter, randomized, controlled, double-blind, placebo-controlled post-market clinical trial and a registration study.
The randomized clinical trial included subjects (n =798) will be randomly divided into experimental (n = 532) and control groups (n =266) according to a random number table. Patients in the experimental group will receive Huaier Granule (20g/time, 3 times/d). Patients in the control group will receive placebo (20g/time, 3 times/d). The registration study plan to recruitment at least 300 patients.
The primary outcome measures is disease-free survival，secondary outcome measures is 2-year overall survivals, ECOG-performance status, Karnofsky performance score and tumor markers (CEA、CYFRA21-1、SCC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with complete resection who are at TNM (primary tumor, regional nodes, metastasis) stage II-Ⅲa, postoperative pathology confirmed for non-small cell lung cancer;
- •Has completed four cycle standard solution of adjuvant chemotherapy, or refused to accept the postoperative adjuvant chemotherapy;
- •Patients between 18 and 70 years old, no gender restriction;
- •Eastern Cooperative Oncology Group (ECOG) PS of two or less;
- •Before the start of the study, patient fully understands the study and is willing to sign the informed consent form;
排除标准
- •Receiving adjuvant chemotherapy patients started greater than 24 weeks from surgical resection;
- •Refused adjuvant chemotherapy patients started greater than 8 weeks from surgical resection;
- •Suspected malignant pleural effusion;
- •There is no clear pathological diagnosis;
- •Combined with other cancer;
- •Patient have a positive surgical margin;
- •Accept other treatment for lung cancer of postoperative；
- •Combined with severe idiopathic disease of liver, kidney and hematopoietic system;
- •Combined psychosis or AIDS;
- •Allergy to the test drug;
- •Pregnant or lactating women;
- •Participation in any other clinical trial within three months;
- •Conditions that are considered not suitable for this study investigators.
研究组 & 干预措施
placebo
placebo
干预措施: placebo (Other)
Huaier Granule
Huaier Granule
干预措施: Huaier Granule (Drug)
结局指标
主要结局
disease-free survival
时间窗: 2-year
disease-free survival
次要结局
- CEA(2-year)
- overall survivals(2-year)
- ECOG-PS(2-year)
- KPS(2-year)
- Quality of Life(2-year)
- CYFRA21-1(2-year)
- SCC(2-year)