An Open Label, Prospective, Multicentre, Non-interventional Study of Apatinib for Chemotherapy-Refractory Advanced Metastatic Gastric Cancer

Metastatic Gastric Cancer Clinical Trial

— AHEAD-G202  

Official title:

An Open Label, Prospective, Multicentre, Non-interventional Study of Apatinib for Chemotherapy-Refractory Advanced Metastatic Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02668380
• Other study ID #: AHEAD-G202
• Status: Recruiting
• Phase: N/A
• First received: December 5, 2015
• Last updated: January 28, 2016
• Start date: September 2015
• Est. completion date: May 2019

Study information

• Verified date: January 2016
• Source: Peking Union Medical College Hospital
• Contact: Chunmei Bai, MD
• Phone: 86-10-69155817
• Email: baichunmei1964[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

This is an Open Label, Prospective, Multicentre, Non-interventional Study of Apatinib for Chemotherapy-Refractory Advanced Metastatic Gastric Cancer, the investigators opted to give patients for apatinib 850 mg once daily, 28 days for a cycle. To evaluate the safety and efficacy of apatinib for Advanced Metastatic Gastric Cancer in the real world.

Description:

In the last decade, front-line chemotherapy has been considered a standard therapeutic regimen for the extension of survival time in patients with metastatic gastric cancer (mGC). New evidence suggests that salvage chemo-therapies, as second-line treatments, may have a survival advantage when compared with best supportive care. After failure of second-line chemotherapy, the results of further treatment are poor, yielding response rates of 0% to 5% with no evidence of prolonged survival. Apatinib is a small-molecule VEGFR-2 tyrosine kinase inhibitor, Had been approved by the CFDA for the treatment of advanced gastric cancer, However, this study defines a variety of inclusion/exclusion criteria, efficacy and safety are not well reflect in the real world for the treatment of advanced gastric cancer. Therefore, an Open Label, Prospective, Multicentre, Non-interventional Study could evaluate the safety and efficacy of apatinib for Advanced Metastatic Gastric Cancer in the real world.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 2019
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• »18 years old

• Advanced Metastatic Gastric Cancer

• The doctor evaluate that patients had benefit from treatment

• The patients signed the written informed consent

Exclusion Criteria:

• Apatinib has been confirmed for allergy sufferers

• Pregnant or lactating women

• Patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, within 30 days after major surgery, uncontrolled high blood pressure medication, III-IV level cardiac insufficiency, severe liver and kidney dysfunction)

• Doctors think doesn't inclusion

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Metastatic Gastric Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
China	Department of Oncology and Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Treatment-related toxicities were graded according to Common Terminology Criteria Adverse Events (CTCAE) version 4.0.	1 years	No
Secondary	Overall survival	Overall survival (OS) was calculated from the date of initial treatment with apatinib to the date of death due to any cause.	1 years	No
Secondary	Progression-free survival	A duration from the date of initial treatment with apatinib to disease progression(as defined by RECIST) or death.	8 months	No
Secondary	Objective response rate	Number of participants who achieve complete response or partial response. Either complete response (CR) or partial response (PR) will be evaluated by RECIST, confirmed at least 4 weeks following the date of the initial response.	5 months	No