A Phase II Study of Raltitrexed-based Chemotherapy Plus Bevacizumab in Retreated Patients With Advanced Colorectal Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- PFS
研究概览
简要总结
The objective is to investigate the efficacy and safety of raltitrexed-based chemotherapy plus bevacizumab in the treatment of advanced colorectal cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-70 years;
- •histological and/or cytological confirmation of ACC;
- •disease progression while on first-line palliative fluoropyrimidine-based chemotherapy or relapse within 6 months after adjuvant chemotherapy;
- •at least one measurable objective tumor lesion by spiral CT examination, the maximum diameter ≥ 1cm（according to RECIST 1.1）
- •ECOG performance status 0-1
- •life expectancy of at least 3 months
- •satisfactory main organ function，laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/L, neutrophil count（ANC） ≥1.5×109/L, platelet count（PLT） ≥80×109/L, Serum creatinine（CR）≤1.5 upper normal limitation (UNL)，total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), Alkaline phosphatase（ALP）≤3 UNL(For patients with liver metastasis, the ALP must be ≤5.0 UNL);
- •written informed consent
排除标准
- •prior exposure to raltitrexed;
- •Clinically significant cardiovascular disease, for example symptomatic coronary artery disease, myocardial infarction (<=6 months before treatment start),congestive heart failure （New York Heart Association ，NYHA>= grade 3）,stroke or transient ischemic attack
- •Accept kidney dialysis treatment now
- •chronic enteropathy on unresolved bowel obstruction;
- •previous malignant disease other than carcinoma in situ of the cervix or basal cell carcinoma of the skin;
- •the UGT1A1 *28（7/7）*6（A/A） gene type;
- •pregnant or lactated women;
- •Unsuitable for the study or other chemotherapy determined by investigator.
研究组 & 干预措施
Raltitrexed and Irinotecan（RALIRI） plus Bevacizumab(AVASTIN)
Irinotecan:250mg/m2 iv,90min,d1, Raltitrexed:3.0mg/m2,iv,15min,d1, Bevacizumab:7.5mg/kg iv,30min,d1,q3w. Maintenance: Raltitrexed(3.0mg/m2,iv,15min,d1,q3w)+Bevacizumab(7.5 mg/kg q3w)
干预措施: Raltitrexed (Drug)
Raltitrexed and Irinotecan（RALIRI） plus Bevacizumab(AVASTIN)
Irinotecan:250mg/m2 iv,90min,d1, Raltitrexed:3.0mg/m2,iv,15min,d1, Bevacizumab:7.5mg/kg iv,30min,d1,q3w. Maintenance: Raltitrexed(3.0mg/m2,iv,15min,d1,q3w)+Bevacizumab(7.5 mg/kg q3w)
干预措施: Irinotecan (Drug)
Raltitrexed and Irinotecan（RALIRI） plus Bevacizumab(AVASTIN)
Irinotecan:250mg/m2 iv,90min,d1, Raltitrexed:3.0mg/m2,iv,15min,d1, Bevacizumab:7.5mg/kg iv,30min,d1,q3w. Maintenance: Raltitrexed(3.0mg/m2,iv,15min,d1,q3w)+Bevacizumab(7.5 mg/kg q3w)
干预措施: Bevacizumab (Drug)
Raltitrexed and Oxaliplatin（RALOX） plus Bevacizumab(AVASTIN)
Oxaliplatin:130mg/m2 iv,120min,d1, Raltitrexed:3.0mg/m2,iv,15min,d1, Bevacizumab:7.5mg/kg iv,30min,d1,q3w. Maintenance: Raltitrexed(3.0mg/m2,iv,15min,d1,q3w)+Bevacizumab(7.5 mg/kg q3w)
干预措施: Raltitrexed (Drug)
Raltitrexed and Oxaliplatin（RALOX） plus Bevacizumab(AVASTIN)
Oxaliplatin:130mg/m2 iv,120min,d1, Raltitrexed:3.0mg/m2,iv,15min,d1, Bevacizumab:7.5mg/kg iv,30min,d1,q3w. Maintenance: Raltitrexed(3.0mg/m2,iv,15min,d1,q3w)+Bevacizumab(7.5 mg/kg q3w)
干预措施: Oxaliplatin (Drug)
Raltitrexed and Oxaliplatin（RALOX） plus Bevacizumab(AVASTIN)
Oxaliplatin:130mg/m2 iv,120min,d1, Raltitrexed:3.0mg/m2,iv,15min,d1, Bevacizumab:7.5mg/kg iv,30min,d1,q3w. Maintenance: Raltitrexed(3.0mg/m2,iv,15min,d1,q3w)+Bevacizumab(7.5 mg/kg q3w)
干预措施: Bevacizumab (Drug)
结局指标
主要结局
PFS
时间窗: 6 months
Progression Free Survival
次要结局
- OS(15 months)
- ORR(36 months)
- DCR(36 months)
- AEs(36 months)
研究者
Liangjun Zhu M.M.
Ward Director of Internal Medicine
Jiangsu Cancer Institute & Hospital