The Clinical Efficacy of Patient-derived Organoid-based Drug Sensitive Neoadjuvant Chemotherapy Versus Traditional Neoadjuvant Chemotherapy in Advanced Gastric Cancer: a Prospective Multi-center Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Objective Response Rate
研究概览
简要总结
Neoadjuvant chemotherapy has become the mainstream recommended treatment for advanced gastric cancer. However, due to the heterogeneity of gastric cancer, part of some patients fail to benefit from the treatment. This project aims to compare the clinical efficacy of individualized neoadjuvant therapy based on patient-derived organoid drug sensitivity assay and traditional regimen, exploring the advantages and disadvantages of these two treatments. And access the safety and clinical value of the personalized neoadjuvant therapy based on patient-derived organoid drug sensitivity assay in advanced gastric cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Age between 18 and 80 years
- •A biopsy proven histological diagnosis of gastric adenocarcinoma or high-grade intraepithelial neoplasia
- •Tumor located at stomach
- •Chest/abdomen/pelvis CT scans or gastric cancer staging CT scan evaluate the clinical stage of tumor as stage III:
- •A. preoperative staging cT3-4N1-2 B. excluding distant organ metastasis (M0)
- •Eastern Cooperative Oncology Group (ECOG) score ≤1
- •Willing to participate and informed consent signed
排除标准
- •Pregnant or lactating women
- •Synchronous or heterochronic malignant carcinomas
- •History of malignant carcinomas
- •Clinical evidence of metastasis
- •Abnormal heart, lung, liver, kidney, hematopoietic function and bone marrow reserve function, unable to tolerate surgical treatment and chemotherapy
- •Mental illness or other serious cardiovascular disease
- •Emergency procedure
研究组 & 干预措施
PDO group
Patients with stage III gastric cancer who need neoadjuvant chemotherapy before radical surgery are recruited. And they are treated with individualized neoadjuvant therapy under the guidance of a patient-derived organoid (PDO)-based drug sensitivity assay.
干预措施: PDO group (Drug)
PDO group
Patients with stage III gastric cancer who need neoadjuvant chemotherapy before radical surgery are recruited. And they are treated with individualized neoadjuvant therapy under the guidance of a patient-derived organoid (PDO)-based drug sensitivity assay.
干预措施: Traditional group (Drug)
Traditional group
Patients with stage III gastric cancer who need neoadjuvant chemotherapy before radical surgery are recruited. In this group, patients are treated with the SOX regimen.
干预措施: PDO group (Drug)
Traditional group
Patients with stage III gastric cancer who need neoadjuvant chemotherapy before radical surgery are recruited. In this group, patients are treated with the SOX regimen.
干预措施: Traditional group (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: an average of 1 year
proportion of patients whose tumor volume reduced to a predetermined value and maintain the minimum time limit.
次要结局
- postoperative complication(an average of 1 year)
- postoperative tumor regression grading(an average of 1 year)
- 3-year recurrence rate(an average of 3 year)
- chemotherapy tolerance and adverse reaction rate(an average of 1 year)
- R0 resection rate(an average of 1 year)