NCT04499586Unknown2 期
A Phase II Trial of Radiotherapy Combined With Raltitrexed and Irinotecan(CPT-11) in Patients With Metastatic or Locally Recurrent Colorectal Cancer
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- ORR(Objective Response Rate) includes CR(Complete Rate) and PR(Partial Rate)
研究概览
简要总结
The study evaluates the effectiveness of radiotherapy combined with raltitrexed and irinotecan in treating patients who have metastatic or locally recurrent colorectal cancer that has not responded to fluorouracil. The patients will receive radiotherapy combined with raltitrexed and irinotecan, and then the surgeons will evaluate whether they should receive a surgery.
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
- •Histologically proven metastatic, advanced, or locally recurrent fluorouracil (5-FU) and oxaliplatin refractory adenocarcinoma of the colon or rectum; Progression of disease within 6 months of receiving adjuvant 5-FU and oxaliplatin chemotherapy OR Progression of disease during or following completion of 5-FU and oxaliplatin chemotherapy for metastatic disease
- •Evaluable lesions with indications of radiotherapy
- •No other metastatic lesions in the radiation field
- •Karnofsky Performance Status>=70
- •UGT1A1*28 6/6 or 6/7
- •Subject blood routine and biochemical indicators meet the following criteria: hemoglobin ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; Alanine transaminase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal; alkaline phosphatase (ALP) ≤2.5 times the normal upper limit; serum total bilirubin <1.5 times the normal upper limit; serum creatinine <1 times the normal upper limit; serum albumin ≥ 30g / L
- •Able to follow the protocol during the study period
- •Sign the inform consent
排除标准
- •Pregnant or breastfeeding women
- •If there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance.
- •Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention (see appendix 12), or a history of myocardial infarction in the last 12 months
- •Organ transplantation requires immunosuppressive therapy
- •Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases
- •Anyone who is allergic to any research medication
结局指标
主要结局
ORR(Objective Response Rate) includes CR(Complete Rate) and PR(Partial Rate)
时间窗: 20 weeks
次要结局
- PFS(Progression Free Survival)(24 months)
- the morbidity of hematological adverse events and diarrhea as assessed by CTCAE v4.0(20 weeks)
- DCR(Disease Control Rate)(20 weeks)
研究者
研究点 (1)
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