Apatinib Treatment as the Neoadjuvant Therapy in Advanced Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT03377842|
Recruitment Status : Not yet recruiting
First Posted : December 19, 2017
Last Update Posted : December 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Neoadjuvant Therapy||Drug: FOLFOX regimen Drug: apatinib and FOLFOX regimen||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Real World Study of Efficacy and Safety for Apatinib Treatment as the Neoadjuvant Therapy in Advanced Colorectal Cancer|
|Estimated Study Start Date :||January 31, 2018|
|Estimated Primary Completion Date :||August 1, 2020|
|Estimated Study Completion Date :||September 1, 2020|
Active Comparator: FOLFOX regimen
FOLFOX regime alone.
Drug: FOLFOX regimen
FOLFOX(Oxaliplatin 85 mg/m² IV infusion and leucovorin 200 mg/m² IV infusion， followed by Fluorouracil 400 mg/m² IV bolus , followed by Fluorouracil 600 mg/m²/h IV infusionas a 22-hour continuous infusion). Repeat cycle every 2 weeks for a total of 6 cycl
Experimental: Apatinib and FOLFOX regimen
Apatinib combine with FOLFOX regimen.
Drug: apatinib and FOLFOX regimen
Apatinib, 500mg p.o. qd, Repeat cycle every 2 weeks for a total of 6 cycles. FOLFOX regime, Repeat cycle every 2 weeks for a total of 6 cycles.
- R0 ,R1 or R2 resection [ Time Frame: 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) [ Time Frame: 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.
- ORR(objective response rate) [ Time Frame: after 8 weeks ]The objective response rate (CR and PR) will be evaluated by the investigator with RECIST v1.1 criteria after 4 cycles.
- Overall survival (OS) [ Time Frame: 14 months ]Overall survival is defined as the time from randomization to death any cause or last follow-up news for patients alive (censored data).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377842
|Contact: Gaoping Zhao, firstname.lastname@example.org|
|Study Chair:||Gaoping Gaoping, doctor||Sichuan province hospital|