Transarterial Chemoembolization With Lipiodol in the Treatment of Initial Unresectable Gastric Cancer (GC)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- OS
研究概览
简要总结
This is a prospective, open-labelled study to evaluate the efficacy and safety of sequential transarterial chemoembolization with lipiodol and neoadjuvant chemotherapy in the treatment of Initial unresectable 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
- •Pathological and imaging diagnosis of gastric adenocarcinoma with initial unresectable R0;
- •Age (18-80 years old) and gender are not limited;
- •No extragastric organ transfer;
- •No serious diseases of the heart, liver, lung, kidney and other organs;
- •Expected survival time > 3 months;
- •Physical performance status score ECOG ≤1 point;
- •Females of reproductive age must have a negative pregnancy test; or male and female patients must agree to use effective contraception during treatment and within 1 year thereafter.
排除标准
- •Poor coagulation function, INR>1.5, or ongoing anticoagulation therapy or known bleeding diseases;
- •WBC <3000/mm3 or platelet count <50000/mm3;
- •AST and/or ALT > 3 times the upper limit of normal;
- •Comorbidities or social environment that can cause subjects to fail to follow the research plan or even endanger patient safety;
- •The patient has other primary tumors.
研究组 & 干预措施
Transarterial Chemoembolization With Lipiodol for Initial Unresectable Gastric Cancer
干预措施: Transarterial Chemoembolization (Drug)
结局指标
主要结局
OS
时间窗: up to 3 years
Overall survival (OS), defined as the time from study entry (ie, signing the ICF) to death from any cause. For subjects who were alive at the last contact, their overall survival was censored on the date of the last contact.
Efficacy evaluation
时间窗: up to 3 years
Objective response rate (ORR): complete response (CR) + partial response (PR). Evaluation methods: Objective tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Subjects must have measurable tumor lesions at baseline, and the efficacy evaluation criteria are divided into complete remission (CR), partial remission (PR), stable disease (SD), and progressive disease (PD) according to RECIST 1.1 criteria. Complete Remission (CR): All target and non-target lesions disappeared, no new lesions; Partial Remission (PR): Compared with baseline, tumor burden decreased by ≥30%, and non-target lesions did not progress significantly , no new lesions; Stable Disease (SD): neither PR nor PD; Progressive Disease (PD): tumor burden increased by ≥20%, and the absolute value increased by at least 5mm, or non-target lesions progressed, or new lesions (reconfirm progression after at least 6 weeks).
Surgical resection rate
时间窗: up to 3 years
Surgical resection rate: The rate of surgical resection is transformed from those who cannot undergo radical surgical resection and one-stage anastomosis after treatment.
PFS
时间窗: up to 3 years
Progression-free survival（PFS） is defined as the time between the date of randomization and any documented tumor progression or death from any cause.
次要结局
未报告次要终点
研究者
Gang Wu
Chief physician
The First Affiliated Hospital of Zhengzhou University