NCT04923620招募中不适用
Efficacy and Safety of Neoadjuvant Cetuximab + Chemotherapy Combined With Short-course Radiotherapy for RAS Wild-type Locally Advanced Rectal Cancer
Shanghai Minimally Invasive Surgery Center1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2021年10月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Pathological response rate
研究概览
简要总结
Prospectively Investigate the effectiveness and safety of neoadjuvant cetuximab + chemotherapy (mFOLFOX6) combined with short-course radiotherapy (25Gy/5Fx) for RAS wild-type locally advanced rectal cancer
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •A biopsy proven histological diagnosis of rectal adenocarcinoma；
- •An ARMS-PCR proven KRAS, NRAS, PI3KCA and BRAF wild type;
- •No intestinal obstruction, distant metastasis was excluded by CT, MRI or PET / CT;
- •MRI proven T3c-T4, CRM positive, N2, extramural vascular invasion positive or lateral lymph node positive of locally advanced rectal cancer;
- •Age between 18-75 years;
- •ECOG (Eastern US Cooperative Oncology Group) score: 0-1;
- •Has sufficient organ function:
- •Hemopoietic function: hemoglobin ≥ 90 g / L, platelet ≥ 80 g / L × 109 / L, neutrophils ≥ 1.5 × 109/L
- •Liver function: ALT and AST < 2.5 × ULN;
- •Renal function: serum creatinine < 1.5 ULN;
- •Willing to participate and informed consent signed；
排除标准
- •Patients with mutations in any of KRAS, NRAS, or BRAF, microsatellite instablility-High;
- •Patients having undergone chemotherapy, radiotherapy or surgery for colorectal cancer;
- •Patients with other uncontrolled malignant tumors (except early-stage basal cell carcinoma or cervical carcinoma in situ) ;
- •Female patients who are pregnant or breastfeeding;
- •Patients with severe heart, liver, or kidney, or neurological or psychiatric disease;
- •Patients with active infection;
- •Poor overall health status, ECOG ≥ 2;
- •Patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study in the judgment of the investigator;
- •Known hypersensitivity reactions to any investigational drugs;
结局指标
主要结局
Pathological response rate
时间窗: two weeks after surgery
Tumor Regression Grade 0-1
次要结局
- Pathological complete response rate(two weeks after surgery)
- 2-year local control rate(2 years after enrollment)
- 2-year metastasis-free rate 2-year distant metastasis free rate(2 years after enrollment)
- Overall survival(2 years after enrollment)
- disease-free survival(2 years after enrollment)
研究者
Cai Zhenghao
MD
Shanghai Minimally Invasive Surgery Center
研究点 (1)
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