NCT05795296进行中（未招募）2 期
Clinical Study of Fruquintinib in Combination With Sintilimab as a First-line Therapy in Gastric Adenocarcinoma/Adenocarcinoma of Esophagogastric Junction
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
The goal of this clinical trial is to explore the efficacy and safety in patients with gastric adenocarcinoma or adenocarcinoma of esophagogastric junction. The main questions it aims to answer are:
- Does this therapy have a promising efficacy?
- Does this therapy have a manageable toxicity? Participants will receive fruquintinib plus sintilimab as first-line therapy for gastric cancer.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological confirmed advanced, recurrent, of metastatic gastric adenocarcinoma or adenocarcinoma of esophagogastric junction;
- •ECOG PS: 0-2;
- •Adequate hepatic, renal, heart, and hematologic functions;
- •At least one measurable lesion (according to RECIST1.1);
- •Haven't received any systematic treatment for the cancer involved;
- •Expected survival > 12 weeks;
- •Contraception until 6 months after the study termination;
- •Signed informed consent.
排除标准
- •Her-2-positive gastric cancer, or exposed to any immune checkpoint inhibitor;
- •Participated in another study;
- •Immunodeficiency;
- •Received allograft；
- •Unmanageable hypertension, diabetes, or coronary disease;
- •Have difficulty in taking medicine, or active bleeding;
- •Pulmonary tuberculosis, or interstitial lung disease that needs steroid therapy;
- •Infection of HIV, HBV, HCV, or other unmanageable infection;
- •Other malignant tumor history;
- •Allergic to the test drug;
- •Other diseases which will affect the results of this study;
- •Received resection of stomach;
- •Taking anti-tumor traditional Chinese Medicine;
- •Severe active bleeding.
研究组 & 干预措施
Fruquintinib+Sintilimab
Experimental
Fruquintinib: 5mg po, d1-d14, q3w
Sintilimab: 200mg ivgtt, d1, q3w
干预措施: Fruquintinib (Drug)
Fruquintinib+Sintilimab
Experimental
Fruquintinib: 5mg po, d1-d14, q3w
Sintilimab: 200mg ivgtt, d1, q3w
干预措施: Sintilimab (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: 12 months
The proportion of patients with complete response or partial response, using RECIST v 1.1.
次要结局
- Disease Control Rate (DCR)(12 months)
- Progression-Free Survival (PFS)(12 months)
- Overall survival (OS)(12 months)
- Adverse Events(12 months)
研究者
研究点 (1)
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