An Open Single Arm Exploratory Study of Apatinib Mesylate Tablets in Combination With Raltitrexed Treatment in Patients With Advanced Colorectal Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
30 patients with advanced colorectal cancer will be enrolled to observe the efficacy and safety of raltitrexed combined with apatinib as a third-line treatment.
详细描述
In this study, we plan to enroll 30 patients with advanced colorectal cancer after failure of second-line standard chemotherapy. The therapeutic regimen is raltitrexed, 3 mg/㎡, ivgtt, d1, apatinib 500 mg, qd,po, d1-21, Every 3 weeks for 1 cycles, the primary end point was PFS, the secondary end point was OS, DCR, ORR etc. Aim to observe the efficacy and safety of raltitrexed combined with apatinib as a third-line treatment of in patients with advanced colorectal 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Male or female, ≥ 18 of age;
- •2.Histological confirmed advanced colorectal adenocarcinoma，and at least one measurable lesion;
- •3.Have failed for ≥ 2 lines of standard chemotherapy(included Fluorouracil, irinotecan and oxaliplatin);
- •4.ECOG performance status 0-2;
- •5.Life expectancy of more than 3 months;
- •6.The main organs function is well, and randomized within 14 days before the relevant inspection indicators to meet the following requirements:
- •blood routine test Hgb ﹥90g/L, ANC﹥1.5×109/L, Platelets ﹥ 100×109/L,
- •biochemical tests Serum Total bilirubin ≤ 1.5 X UNL(upper normal limit), ALT or AST ≤ 2 xUNL, and ﹤ 5 x UNL（Hematogenous metastases）, Creatinine clearance rate≥ 60 ml/min(Cockcroft-Gault formula),
- •Doppler echocardiography assessment：LVEF ≥ 50%;
- •7.No serious heart, lung, liver, kidney dysfunction; no jaundice and gastrointestinal obstruction; no acute infection;
- •8.Signed informed consent;
- •9.Good compliance, and family members agree to receive survival follow-up.
排除标准
- •1.Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
研究组 & 干预措施
raltitrexed combined with apatinib
therapeutic regimen : raltitrexed, 3 mg/㎡, ivgtt, d1, apatinib 500 mg, QD po, d1-21, Every 3 weeks for 1 cycles.
干预措施: raltitrexed combined with apatinib (Drug)
结局指标
主要结局
PFS
时间窗: 6 months
Progression-free survival progression-free survival
次要结局
- OS(12 months)
- ORR(12 months)
- DCR(12 months)
研究者
Dai, Guanghai
Department Director,M.D.
Chinese PLA General Hospital