Qizhu Yuling Prescription in the Prevention and Treatment of Postoperative Metastasis and Recurrence of Esophagus Cancer：A Randomized, Double-blind, Controlled and Multi-center Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 310
- 试验地点
- 3
- 主要终点
- 1-year disease-free survival rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Qizhu Yuling prescription for postoperative esophagus cancer.
详细描述
This study include a multi-center, randomized, double-blind, placebo, parallel controlled clinical trial.The randomized clinical trial will enroll approximately 310 patients. Participants will be randomly divided into experimental (n=155) and placebo groups (n=155).Patients in the experimental group was treated with Qizhu Yuling prescription within 6 months after esophagus cancer R0. Patients in the control group will receive the placebo.The primary endpoint is 1-year DFS (Disease-free survival) rate after surgery, that refers to the proportion of patients who do not have recurrence, metastasis or death (from any cause) within 1 years after surgery. The research protocol was approved by the relevant ethics committees, and the study was conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Patients gave written informed consent to participate in the trial.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Esophageal cancer without esophagogastric junction pT1-4aN + M0 (stage IIB-IVA) meeting the diagnostic criteria without recurrence or metastasis;
- •Patients who have completed adjuvant therapy (including adjuvant radiotherapy, adjuvant chemotherapy, adjuvant chemotherapy + radiotherapy) within 6 months after R0 resection for esophageal cancer;
- •ECOG score 0-2;
- •18-75 years old;
- •Expected survival ≥ 3 months;
- •Subjects voluntarily signed informed consent.
排除标准
- •Combined with primary tumor at other sites;
- •Patients complicated with severe primary diseases of heart, cerebral vessels, liver, kidney and hematopoietic system;
- •Patients with mental illness and mental and language disorders;
- •Participation in other clinical trials within 3 months;
- •Patients with known hypersensitivity or intolerance to study drug.
研究组 & 干预措施
Qizhu Yuling Prescription
Qizhu Yuling Prescription
干预措施: Qizhu Yuling Prescription (Drug)
Placebo Comparator
Simulation agent of Qizhu Yuling Prescription Group
干预措施: Placebo (Drug)
结局指标
主要结局
1-year disease-free survival rate
时间窗: The day of surgery until the first year
Refers to the proportion of patients who did not experience recurrence, metastasis or death (from any cause) within 1 years after surgery.
次要结局
- Cumulative annual recurrence and metastasis rate for 1-3 years(The day of surgery until the once, second and third year.)
- Indexes related to fat distribution(before and after every third cycles of treatment (each cycle is 28 days), assessed up to recurrence and metastasis (up to 3 years after surgery).)
- Evaluation of the patient's symptoms (MDASI-TCM)(Before and after every cycle of treatment (each cycle is 28 days), assessed up to death or 3 years after surgery.)
- Medication compliance(From randomization to the end of the sixth course of medication （up to 24 weeks）.)
- Visceral Adiposity Index(before and after every third cycles of treatment (each cycle is 28 days), assessed up to recurrence and metastasis (up to 3 years after surgery).)
- Peripheral blood inflammatory index LNR(before and after every third cycles of treatment (each cycle is 28 days), assessed up to recurrence and metastasis (up to 3 years after surgery).)
- Quality of life of the patient (QLQ-QES18)(Before and after every cycle of treatment (each cycle is 28 days), assessed up to death or 3 years after surgery.)
- Tumor marker(before and after every third cycles of treatment (each cycle is 28 days), assessed up to recurrence and metastasis (up to 3 years after surgery).)
- Disease-free survival(Randomization until disease recurrence, metastasis, death (from any cause) , or 36 months after surgery, whichever occurs first.)
- Overall survival(Randomization until death (from any cause) or 36 months after surgery, whichever occurs first.)
- Cumulative annual survival rate for 1-3 years(The day of surgery until the once, second and third year.)
- Peripheral blood inflammatory index LMR(before and after every third cycles of treatment (each cycle is 28 days), assessed up to recurrence and metastasis (up to 3 years after surgery).)
- Prognostic nutritional index(before and after every third cycles of treatment (each cycle is 28 days), assessed up to recurrence and metastasis (up to 3 years after surgery).)
- Percentage of Participants With Adverse Events(aseline until disease progression, death, or assessed up to 36 months after surgery.)
研究者
Jie Li
Vice President
Guang'anmen Hospital of China Academy of Chinese Medical Sciences