Patient-derived Tumor-like Cell Clusters (PTC) in Personalizing Neoadjuvant Therapy for Patients With Advanced Gastrointestinal Tumor: A Prospective, Open-label and Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 420
- 主要终点
- pathological complete response rate(pCR)
研究概览
简要总结
To explore the value of PTC drug screening technique in selecting neoadjuvant therapy for advanced gastrointestinal cancer.
详细描述
In this study, patients diagnosed with advanced gastrointestinal cancer including locally advanced gastric cancer, locally advanced colorectal cancer and colorectal cancer with liver metastasis. Tumor sample will be collected by endoscopy biopsy, needle biopsy or surgery, which will used for PTC drug screening.
Patients will be randomized to two groups. Patients in experiment group will receive neoadjuvant therapy based on PTC drug screening, and patients in control group will receive neoadjuvant therapy based on clinical experience. 2-4 cycles of neoadjuvant therapy will be administered. Patients appropriate for surgery will receive radical surgery after neoadjuvant therapy. Pathological response will be compared primarily between these two groups.
This is a randomized controlled, open-label and sequential designed clinical trial. All neoadjuvant therapy used in this study or for PTC drug screening comply with NCCN (National comprehensive cancer network) or CSCO (Chinese Society of Clinical Oncology) guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- •diagnosed of gastrointestinal adenocarcinoma by biopsy
- •existence of initially resectable lesions evaluated by investigators
- •indications of neoadjuvant chemotherapy including: 1) locally advanced gastric cancer cT1-2N1-3M0 & cT3-4N0-3M0; 2) locally advanced colorectal cancer cT3-4 or N+; 3)colorectal carcinoma with synchronous liver metastases: CRS≤2; 4)other patients who are considered to be appropriate to receive neoadjuvant chemotherapy determined by MDT
- •never receive any tumor related treatment including chemotherapy, radiotherapy, and immune therapy
- •never diagnosed of other malignancies
- •able to tolerate chemotherapy
- •life expectance >6 months
- •at least 1 measurable lesions(according to RECIST 1.1)
- •informed consent
排除标准
- •pregnant or lactating women
- •participating in other clinical trials within 6 months
- •MSI-H or dMMR or EBER(+)
- •lesion located within 10cm from anal margin
- •severe liver dysfunction
- •severe renal dysfunction
- •cognitive disorder, mental disease or poor compliance
- •allergic to known chemotherapeutic agents
- •other conditions not suitable to participate in this trial determined by investigators
结局指标
主要结局
pathological complete response rate(pCR)
时间窗: immediately evaluated after surgery
having no invasive cancer left in the resected sample
次要结局
- objective response rate(ORR)(evaluated by imaging before surgery)
- pathological response rate(immediately evaluated after surgery)
- disease control rate(DCR)(evaluated by imaging before surgery)
- R0 resection rate(immediately evaluated after surgery)
- prediction accuracy of PTC(immediately evaluated after surgery)
研究者
Jiafu Ji
Head of Beijing Cancer Hospital
Peking University