Metastatic Gastric Cancer
Conditions
Keywords
Apatinib, metastatic gastric cancer, Non-interventionalStudy
Brief 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.
Detailed 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.
Interventions
None listed
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Peking Union Medical College Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 1 years | Treatment-related toxicities were graded according to Common Terminology Criteria Adverse Events (CTCAE) version 4.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 1 years | Overall survival (OS) was calculated from the date of initial treatment with apatinib to the date of death due to any cause. |
| Progression-free survival | 8 months | A duration from the date of initial treatment with apatinib to disease progression(as defined by RECIST) or death. |
| Objective response rate | 5 months | 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. |
Countries
China
Contacts
Primary ContactChunmei Bai, MD
Outcome results
None listed