A Phase II, Single-Arm, Single-Center Study of Fruquintinib Combined With Standard Chemotherapy for Postoperative Treatment of HER2-Negative Gastric Cancer Patients With Poor Tumor Regression Grade.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- 3-year recurrence-free survival rate
研究概览
简要总结
Given that a significant proportion of locally advanced gastric cancer patients still die from tumor recurrence after surgery, with long-term therapeutic outcomes stagnating and difficult to further improve, especially for patients with poor tumor regression grade (TRG) after surgery, this study aims to explore a new model of adjuvant therapy by conducting research on the use of Fruquintinib in combination with standard chemotherapy for postoperative treatment of HER2-negative gastric cancer patients with poor TRG, in order to bring greater survival benefits to patients.
详细描述
Given that a significant proportion of locally advanced gastric cancer patients still die from tumor recurrence after surgery, with long-term therapeutic outcomes stagnating and difficult to further improve, especially for patients with poor tumor regression grade (TRG) after surgery, this study aims to explore a new model of adjuvant therapy by conducting research on the use of Fruquintinib in combination with standard chemotherapy for postoperative treatment of HER2-negative gastric cancer patients with poor TRG, in order to bring greater survival benefits to patients. The primary endpoint of this study is to evaluate the recurrence-free survival (RFS) in patients with poor TRG after neoadjuvant chemotherapy for gastric cancer who receive adjuvant therapy with Fruquintinib combined with standard chemotherapy postoperatively. Secondary endpoints include overall survival (OS) and safety .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Fully understand the study and voluntarily sign the informed consent form;
- •Age between 18 and 75 years;
- •Histologically confirmed resectable or potentially resectable locally advanced gastric/gastroesophageal junction adenocarcinoma;
- •Tumor Regression Grade (TRG) 2 or 3 after preoperative adjuvant therapy;
- •R0 resection after neoadjuvant chemotherapy;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- •Life expectancy of at least 2 years;
- •No prior anti-cancer treatment received;
- •Good compliance and cooperation with follow-up.
排除标准
- •Inability to comply with the study protocol or procedures;
- •History of prior gastric cancer surgery;
- •Contraindications to surgical treatment and chemotherapy or physical condition and organ function that do not allow for major abdominal surgery;
- •Distant metastasis to organs other than the liver, such as lung, brain, and bone;
- •Known HER2-positive patients;
- •Uncontrolled hypertension despite medication prior to enrollment;
- •Poorly controlled diabetes despite medication prior to enrollment;
- •Urine routine indicating proteinuria ≥2+, and a 24-hour urine protein quantification >1.0g;
- •Presence of conditions requiring intervention such as bleeding, perforation, or obstruction prior to enrollment;
- •Patients deemed ineligible for this study by the investigator.
研究组 & 干预措施
Experimental group
Fruquintinib Combined with Standard Chemotherapy
干预措施: Fruquintinib (Drug)
结局指标
主要结局
3-year recurrence-free survival rate
时间窗: Three years after surgery
Percentage of recurrence-free patients within 3 years of surgery
次要结局
- Overall survival(OS is the time interval from the start of treatment to death due to any reason or lost of follow-up，whichever came first, assessed up to 3 years")
- AEs-Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(from the first drug administration to within 30 days for the last dose)