Apatinib Treatment as the Neoadjuvant Therapy in Advanced Colorectal Cancer
Primary Purpose
Colorectal Cancer, Neoadjuvant Therapy
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
FOLFOX regimen
apatinib and FOLFOX regimen
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring apatinib
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
FOLFOX regimen
Apatinib and FOLFOX regimen
Arm Description
FOLFOX regime alone.
Apatinib combine with FOLFOX regimen.
Outcomes
Primary Outcome Measures
R0 ,R1 or R2 resection
Number of patients (%) with hepatic metastases R0 ,R1 or R2 resection.
Progression-free survival (PFS)
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.
Secondary Outcome Measures
ORR(objective response rate)
The objective response rate (CR and PR) will be evaluated by the investigator with RECIST v1.1 criteria after 4 cycles.
Overall survival (OS)
Overall survival is defined as the time from randomization to death any cause or last follow-up news for patients alive (censored data).
Full Information
NCT ID
NCT03377842
First Posted
December 8, 2017
Last Updated
December 14, 2017
Sponsor
Sichuan Provincial People's Hospital
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03377842
Brief Title
Apatinib Treatment as the Neoadjuvant Therapy in Advanced Colorectal Cancer
Official Title
A Real World Study of Efficacy and Safety for Apatinib Treatment as the Neoadjuvant Therapy in Advanced Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 31, 2018 (Anticipated)
Primary Completion Date
August 1, 2020 (Anticipated)
Study Completion Date
September 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sichuan Provincial People's Hospital
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Neoadjuvant Therapy
Keywords
apatinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FOLFOX regimen
Arm Type
Active Comparator
Arm Description
FOLFOX regime alone.
Arm Title
Apatinib and FOLFOX regimen
Arm Type
Experimental
Arm Description
Apatinib combine with FOLFOX regimen.
Intervention Type
Drug
Intervention Name(s)
FOLFOX regimen
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
apatinib and FOLFOX regimen
Intervention Description
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.
Primary Outcome Measure Information:
Title
R0 ,R1 or R2 resection
Description
Number of patients (%) with hepatic metastases R0 ,R1 or R2 resection.
Time Frame
at least 4-6 weeks after the end of chemotherapy
Title
Progression-free survival (PFS)
Description
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.
Time Frame
8 months
Secondary Outcome Measure Information:
Title
ORR(objective response rate)
Description
The objective response rate (CR and PR) will be evaluated by the investigator with RECIST v1.1 criteria after 4 cycles.
Time Frame
after 8 weeks
Title
Overall survival (OS)
Description
Overall survival is defined as the time from randomization to death any cause or last follow-up news for patients alive (censored data).
Time Frame
14 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gaoping Zhao, doctor
Phone
028-87393805
Email
49482795@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaoping Gaoping, doctor
Organizational Affiliation
Sichuan province hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26884585
Citation
Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction. J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. Epub 2016 Feb 16.
Results Reference
background
Links:
URL
https://www.fda.gov/ScienceResearch/SpecialTopics/RealWorldEvidence/default.htm
Description
descriptions about real world study issued by the FDA
Learn more about this trial
Apatinib Treatment as the Neoadjuvant Therapy in Advanced Colorectal Cancer
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