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Apatinib Treatment as the Neoadjuvant Therapy in Advanced Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03377842
Recruitment Status : Not yet recruiting
First Posted : December 19, 2017
Last Update Posted : December 19, 2017
Jiangsu HengRui Medicine Co., Ltd.
Information provided by (Responsible Party):
Zhao gaoping, Sichuan Provincial People's Hospital

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Neoadjuvant Therapy Drug: FOLFOX regimen Drug: apatinib and FOLFOX regimen Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

  2. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03377842

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Contact: Gaoping Zhao, doctor 028-87393805

Sponsors and Collaborators
Sichuan Provincial People's Hospital
Jiangsu HengRui Medicine Co., Ltd.
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Study Chair: Gaoping Gaoping, doctor Sichuan province hospital
Additional Information:
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Responsible Party: Zhao gaoping, chief physician, Sichuan Provincial People's Hospital Identifier: NCT03377842    
Other Study ID Numbers: APTN-CRC-201712
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhao gaoping, Sichuan Provincial People's Hospital:
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents
Vitamin B Complex