The Efficacy and Safety of Thymosin-alpha 1 Used for Adjuvant Treatment After Radical Resection of High-risk Stage II and Stage III Colorectal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- 3-year disease-free survival rate
研究概览
简要总结
For high-risk stage II and stage III colorectal cancer, even after radical resection and postoperative adjuvant chemo/radiotherapy, 30-40% of patients will still have recurrence and metastasis. Thymosin-alpha 1 is believed to improve immunity and may help promote tumor immunity to reduce the incidence of recurrence and metastasis. This study hopes to verify the effecacy and safety of thymosin-alpha 1 for adjuvant treatment of high-risk stage II and stage III colorectal cancer after radical resection.
详细描述
Patients with pathological high-risk stage II and stage III colorectal cancer after radical resection were randomly allocated to receive thymosin-alpha 1 twice a week for 6 months (experimental group) or not (control group) in a 1:1 ratio. At the same time, all patients will receive chemo/radiotherapy according to the Chinese Standards for Diagnosis and Treatment of Colorectal Cancer. The primary endpoint is 3-year DFS rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
There is no masking for participants or investigators. The outcomes assessors will be blind for the allocation.
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
- •Colorectal cancer receiving radical resection
- •Pathologically diagnosed with high-risk stage II or stage III
- •Eastern Cooperative Oncology Group performance status of 0-2
- •Adequate hepatic, renal, and hematologic function
排除标准
- •Had previously taken any immune-promoting drugs
- •Pregnancy or lactation
研究组 & 干预措施
Thymosin
Patients with pathological high-risk stage II and stage III colorectal cancer after radical resection.
干预措施: Thymosin Alpha1 (Drug)
结局指标
主要结局
3-year disease-free survival rate
时间窗: 3 years
percentage of patients who have no recurrence or metastases or death at 3 years after surgery.
次要结局
- 3-year overall survival rate(3 years)
- rate of adverse events related to thymosin-alpha 1(6 months)