Clinical trial NCT02668380: An Open Label, Prospective, Multicentre, Non-interventional Study of Apatinib for Chemotherapy-Refractory Advanced Metastatic Gastric Cancer
Official title: An Open Label, Prospective, Multicentre, Non-interventional Study of Apatinib for Chemotherapy-Refractory Advanced Metastatic Gastric Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Gastric Cancer
Keywords: Apatinib
metastatic gastric cancer
Non-interventionalStudy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2016-01-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Advanced Metastatic Gastric Cancer

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adverse Events
timeFrame: 1 years
Secondary outcomes:
measure: Overall survival
timeFrame: 1 years
measure: Progression-free survival
timeFrame: 8 months
measure: Objective response rate
timeFrame: 5 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Oncology and Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Chunmei Bai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li N, Bai C, Zhang R, Ma L, Ren X, Zhang J, Fu Z, Zhao L. Efficacy and safety of apatinib for the treatment of AFP-producing gastric cancer. Transl Oncol. 2021 Feb;14(2):101004. doi: 10.1016/j.tranon.2020.101004. Epub 2020 Dec 28.
citation: Wang X, Zhang R, Du N, Yang M, Zang A, Liu L, Yu J, Gao J, Zhang J, Fu Z, Ren Y, Ma L, Guo J, Li Q, Li X, Fan Z, Song X, Liu Z, Zhang Y, Li G, Yu Z, Diao J, Jia J, Liang F, Wang H, Sun J, Gao Y, Yang P, Bai C, Ren X, Zhong D. An open label, multicenter, noninterventional study of apatinib in advanced gastric cancer patients (AHEAD-G202). Ther Adv Med Oncol. 2020 Mar 19;12:1758835920905424. doi: 10.1177/1758835920905424. eCollection 2020.