NCT05111860招募中1 期
Efficacy and Safety of Neoadjuvant Bevacizumab + Chemotherapy Combined With Short-course Radiotherapy for RAS Mutant-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 20 人开始时间: 2022年11月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Peri-operative complications
研究概览
简要总结
Prospectively Investigate the effectiveness and safety of neoadjuvant Bevacizumab + chemotherapy (mFOLFOX6) combined with short-course radiotherapy (25Gy/5Fx) for RAS mutant-type locally advanced rectal 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 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 mutation, excluding BRAF mutation or microsatellite instablility-High;
- •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
- •An ARMS-PCR proven RAS wild type, BRAF mutation and 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;
研究组 & 干预措施
Group 1
Experimental
干预措施: Bevacizumab+mFOLFOX6 (Drug)
结局指标
主要结局
Peri-operative complications
时间窗: From the start of treatment to 3 months after surgery
Complications occurring in the perioperative period
次要结局
- Pathological complete response rate(2 weeks after surgery)
- 2-year local control rate(2 years)
- Pathological response rate(2 weeks after surgery)
- 2-year metastasis-free rate(2 years)
- Overall survival(2 years)
研究者
研究点 (1)
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