Randomized Clinical Trial:Clinical Study of Modified Banxia Xiexin Decoction Treatment on Gastric Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 主要终点
- Overall survival
研究概览
简要总结
Research purpose To elucidate the effect mechanism and clinical effective of Modified Banxia Xiexin Decoction in the prevention and treatment of gastric cancer. From genes related to cell differentiation, proliferation, apoptosis, tumor invasion and metastasis, genes related to immune inflammation and immune escape and other possible aspects to elucidate the effective and mechanism of Modified Banxia Xiexin Decoction's treatment on gastric cancer
详细描述
Modified Banxia Xiexin Decoction treatment and mechanism on Gastric Cancer. Main Responsibility Person: Mingyu Sun research center#Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine Trial Objective#Observe the clinical efficacy and mechanism of Modified Banxia Xiexin Decoction in the treatment gastric cancer Therapeutic Schedule#In this study, 146patients with gastric cancer who received chemotherapy in the Department of Gastrointestinal Surgery and Oncology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine were recruited and divided into groups according to random number table method, namely, 73 patients in the Modified Banxia Xiexin Decoction combined chemotherapy group and 73 patients in the Placebo granules combined chemotherapy group.Modified Banxia Xiexin Decoction group was treated with 18 weeks of Chinese patent medicine Modified Banxia Xiexin Decoction at the same time of chemotherapy. The Overall survival, Progression-free survival, Solid tumor efficacy, TCM syndrome score, quality of life score, Tumor markers, Immune function and adverse reactions of the two groups before and 18 weeks after treatment were observed and compared. Elucidate the possible mechanism of action of Modified Banxia Xiexin Decoction in the treatment of gastric cancer patients.
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
- None
入排标准
- 年龄范围
- 17 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with stage IV gastric cancer with a clear cytological or pathological diagnosis.
- •The patient is willing to receive palliative chemotherapy (more than 6 months between the first treatment or the last chemotherapy).
- •At least one measurable lesion revealed by imaging (PET-CT, CT, MRI, bone scan, x-ray).
- •Expected survival of ≥ 6 months.
- •It is consistent with the diagnosis of spleen qi deficiency and cold-heat mismatch in TCM.
- •Age 18 to 75 years with a physical condition score of ECOG (0-1).
- •The blood count is normal, heart, liver and kidney functions are not abnormal, and the electrocardiogram is basically normal.
- •Patients have good compliance, are able to understand the study and sign an informed consent form.
排除标准
- •Those with a history of severe cardiovascular, urinary, hematological and digestive system diseases.
- •Pregnant or breastfeeding women with uncontrollable mental disorders.
- •With gastrointestinal obstruction or active bleeding in the gastrointestinal tract, as well as perforation and dysphagia.
- •Complications of serious infectious diseases such as active tuberculosis.
- •Those with contraindications to chemotherapy or frequent vomiting.
- •Poor compliance.
- •Patients who have used other trial drugs or in other clinical trials in the past month.
研究组 & 干预措施
combination chemotherapy with Modified Banxia Xiexin Decoction
146 patients with gastric cancer were randomly divided into a treatment group of 73 cases and a control group of 73 cases. The treatment group received combination chemotherapy with Modified Banxia Xiexin Decoction
干预措施: Modified Banxia Xiexin Decoction (Drug)
combination chemotherapy with Placebo granules
The control group received combination chemotherapy with Placebo granules.
干预措施: combination chemotherapy with Placebo granules (Drug)
结局指标
主要结局
Overall survival
时间窗: the patients' were included into the clinical trials and up to 18 weeks treatment
To observe the effects of treatment group and control group on OS in patients with advanced gastric cancer, and evaluate whether there is statistical difference in OS between the two groups.From date of randomization until the date of death from any cause, whichever came first, assessed up to 18 months.
次要结局
- Clinical symptoms(the patients' were included into the clinical trials and up to 18 weeks treatment)
- EORTC QLQ-C30(the patients' were included into the clinical trials and up to 18 weeks treatment)
- Immune function(the patients' were included into the clinical trials and up to 18 weeks treatment)
- Tumor markers(the patients' were included into the clinical trials and up to 18 weeks treatment)
- Progression-free survival(the patients' were included into the clinical trials and up to 18 weeks treatment)
研究者
Mingyu Sun
Clinical Professor
ShuGuang Hospital