A Real World Study of Efficacy and Safety for Apatinib Treatment as the Neoadjuvant Therapy in Advanced Colorectal Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 主要终点
- R0 ,R1 or R2 resection
研究概览
简要总结
Apatinib has been proved to be effective and safe among patients in advanced colorectal cancer in several trials. the investigators aimed to evaluate its efficacy and safety as the neoadjuvant therapy in real world practice, and to explore factors associated with efficacy.
详细描述
Regorafenib (BAY 73-4506, commercial name Stivarga) is an oral multi-kinase inhibitor developed by Bayer which shows anti-angiogenic activity due to its dual targeted VEGFR2-TIE2 tyrosine kinase inhibition.Regorafenib demonstrated to increase the overall survival of patients with metastatic colorectal cancer and has been approved by the CFDA in 2017.
Apatinib, a small molecule receptor tyrosine kinase (RTK) inhibitor, targets the intracellular domain of the VEGFR-2 ATP binding site, and is the first anti-angiogenic therapy approved by the China Food and Drug Administration in December 2014 for the treatment of metastatic gastric cancer in third-line or later treatment. It is an orally bioavailable, small molecule agent which is thought to inhibit angiogenesis in cancer cells; specifically apatinib inhibits VEGF-mediated endothelial cell migration and proliferation thus blocking new blood vessel formation in tumor tissue. It is an investigational cancer drug currently undergoing clinical trials as a potential targeted treatment for metastatic gastric carcinoma, metastatic breast cancer ,advanced hepatocellular carcinoma and advanced colorectal cancer.
Apatinib are often used in advanced colorectal cancer for uses that are not within its approved indication for use.However, the knowledge gained from all uses of apatinib in this medical practice is often not realized because the data collected are not systematically characterized, aggregated, and analyzed in a way that can be relied upon to inform its further usage.
In some cases, a "traditional" clinical trial may be impractical or excessively challenging to conduct. Ethical issues regarding treatment assignment, and other similar challenges, may present themsevels when developing and attempting to execute a high quality clinical trial. Analyses of real-world data(RWD), using appropriate methods, may in some cases provide similar information with comparable or even superior characteristics to information collected and analyzed through a traditional clinical trial. For example, RWD collected using a randomized exposure assignment within a registry can provide a sufficient number of patients for powered subgroup analyses.
the investigators will evaluate the efficacy and safety for Apatinib combine with other chemotherapy regimens as the neoadjuvant therapy in advanced colorectal cancer in a real world study setting. This study leveraging RWD can potentially provide information on a wider patient population, thus providing information that cannot be obtained through a traditional clinical trial alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Age of 18 years or older.
- •Histological or cytological confirmation of adenocarcinoma of the colon or/and rectum;
- •Stage TxNxM1 (truly metastatic disease) with liver metastases only.
- •Patients should be voluntary to the trial and provide with signed informed consent.
- •The researchers believe patients can benefit from the study.
排除标准
- •Patients with a known history of allergic reactions and/or hypersensitivity attributed to apatinib or its accessories.
- •Pregnant or lactating women
- •Patients with Apatinib contraindications
- •Patients of doctors considered unsuitable for the trial
研究组 & 干预措施
FOLFOX regimen
FOLFOX regime alone.
干预措施: FOLFOX regimen (Drug)
Apatinib and FOLFOX regimen
Apatinib combine with FOLFOX regimen.
干预措施: apatinib and FOLFOX regimen (Drug)
结局指标
主要结局
R0 ,R1 or R2 resection
时间窗: at least 4-6 weeks after the end of chemotherapy
Number of patients (%) with hepatic metastases R0 ,R1 or R2 resection.
Progression-free survival (PFS)
时间窗: 8 months
Progression-free survival is defined as the time from randomization to progression (RECIST v1.1 criteria) or death. Patients alive without progression will be censored at the last follow-up.
次要结局
- ORR(objective response rate)(after 8 weeks)
- Overall survival (OS)(14 months)
研究者
Zhao gaoping
chief physician
Sichuan Provincial People's Hospital