NCT07098026招募中不适用
Shenqi Fuwei Mixture Combined With Chemotherapy Neoadjuvant Therapy for Locally Advanced Gastric Cancer: A Multicenter Randomized Controlled Clinical Study
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 286
- 试验地点
- 1
- 主要终点
- EFS
研究概览
简要总结
The purpose of this clinical trial is to investigate whether the drug Shenqi Fuwei Mixture is effective for postoperative recurrence and metastasis of gastric cancer. Safety of Shenqi Fuwei Mixture will also be understood. It aims to answer the main questions:
- Shenqi Fuwei Mixture in perioperative combined with neoadjuvant chemotherapy to reduce the recurrence and metastasis of locally advanced gastric cancer after surgery?
- Shenqi Fuwei Mixture in the prevention and treatment of postoperative recurrence and metastasis of gastric cancer dominant population characteristics and efficacy mechanism?
- Exploratory excavation of TCM syndrome, multi-omics combined means to explore the advantages of Shenqi Fuwei Mixture on postoperative recurrence and metastasis of gastric cancer? The researchers will compare the drug Shenqi Fuwei Mixture with placebo (a substance that does not contain drugs and has a similar appearance) to see if the drug Shenqi Fuwei Mixture can prevent and treat recurrence and metastasis of gastric cancer after surgery.
Participants will:
- Take Shenqi Fuwei Mixture or placebo daily, synchronize with chemotherapy, or until tumor progression or intolerable toxicity
- Visits every 3 weeks for tests and tests
- Their survival status and adverse drug reactions were recorded
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)
盲法说明
Subjects, investigators, image assessors, and statistical analysts were blinded and emergency letters were set up to unblind.
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
- •Gastric or gastroesophageal junction adenocarcinoma confirmed by pathology or cytology;
- •Resectable or potentially resectable gastric cancer with clinical stage of cT3-4aN + M0 or cT4bNxM0;
- •Patients who are not allowed to receive previous anti-tumor therapy including chemotherapy radiotherapy immunotherapy or targeted therapy; Adequate organ function defined as follows: hematological ANC ≥ 1.5 * 10 ^ 9/L hemoglobin ≥ 9 g/dL platelets ≥ 80 * 10 ^ 9/L albumin ≥ 30 g/L serum bilirubin ≤ 1.5 × ULN AST and ALT ≤ 2.5 × ULN ALP ≤ 2.5 × ULN TBIL ≤ 1.5 × ULN renal serum creatinine < 1.5 × ULN.
- •KPS ≥ 70 points;
- •18-75 years old male or female;
- •Subjects voluntarily signed a written informed consent form.
排除标准
- •Associated with distant metastasis;
- •Patients with known hypersensitivity or metabolic disorder to fluorouracil or oxaliplatin or known hypersensitivity or intolerance to the study drug; Patients with primary malignant tumors at other sites. Subjects who were disease-free for 5 years or had a history of completely resected non-melanoma skin cancer or successfully treated carcinoma in situ were eligible;
- •Gastrointestinal emergencies include: inability to swallow (complete or incomplete) gastrointestinal obstruction gastrointestinal bleeding and gastrointestinal perforation;
- •Patients who are pregnant have neurological diseases or mental illness and mental and language disorders;
- •Known uncontrolled angina pectoris arrhythmia congestive heart failure or myocardial infarction or a history of cardiac insufficiency within 6 months prior to study enrollment;
- •Any concurrent disease or condition that may make the subject unsuitable for study participation or any serious medical condition that may interfere with the subject 's safety;
- •Persons who are incapable (legally) or unsuitable for continuing study treatment for ethical/medical reasons.
研究组 & 干预措施
Shenqi Fuwei Mixture
Experimental
Shenqi Fuwei Mixture
干预措施: Shenqi Fuwei Mixture (Drug)
Shenqi Fuwei Mixture Placebo
Placebo Comparator
Shenqi Fuwei Mixture Placebo
干预措施: Shenqi Fuwei Mixture Placebo (Drug)
结局指标
主要结局
EFS
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Event-Free Survival
次要结局
- Surgical conversion rate(Binary classification variables were used to calculate the proportion of patients who could undergo surgery, whichever came first, assessed up to 60 months)
- OS(From date of randomization until the date of death from any cause, whichever came first, assessed up to 60 months)
- Tumor markers("Baseline" or "3 week")
- DFS(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months)
- Infections and complications(Perioperative/Periprocedural)
- FACT-Ga Scale("Baseline" or "At the begin of Cycle 1 (each cycle is 21 days)")
- Adverse events(At the end of Cycle 1 (each cycle is 21 days))
- ESAS Scale("Baseline" or "At the begin of Cycle 1 (each cycle is 21 days)")
- MDASI-TCM Scale("Baseline" or "At the begin of Cycle 1 (each cycle is 21 days)")
研究者
研究点 (1)
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