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

Peking Union Medical College Hospital300 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Metastatic Gastric Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Oncology and Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Adverse Events

Treatment-related toxicities were graded according to Common Terminology Criteria Adverse Events (CTCAE) version 4.0.

Time frame: 1 years

Secondary Outcomes

Overall survival

Overall survival (OS) was calculated from the date of initial treatment with apatinib to the date of death due to any cause.

Time frame: 1 years

Progression-free survival

A duration from the date of initial treatment with apatinib to disease progression(as defined by RECIST) or death.

Time frame: 8 months

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.

Time frame: 5 months

Central Contacts

Chunmei Bai, MD

CONTACT

86-10-69155817 baichunmei1964@163.com

Data from ClinicalTrials.gov

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