A Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer (NCT02426034) | Clinical Trial Compass
CompletedPhase 4
A Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer
China2,004 participantsStarted 2015-05-15
Plain-language summary
The large-scale phase IV study aims to verify the safety and efficacy of apatinib in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma after failure of two lines of chemotherapy. Apatinib initiated at a recommended dose of 850mg. However, the starting dose was decided by investigator's choice based on patients' condition. Dose interruption and dose reduction were allowed according to the product label. Treatment continued until disease progression, intolerable toxicity, withdrawal of informed consent, or at investigators' discretion. The primary endpoint was safety, which was assessed by recording the incidence and severity of adverse events.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age: 18 to75 years old;
. Pathologically diagnosed with advanced gastric cancer (including adenocarcinoma of the gastroesophageal junction);
. Failure of prior therapy (during or after treatment) in patients who have received at least two prior chemotherapy regimens;
. ECOG PS of 0-2;
. Major organ function has to meet the following criteria:
. An expected survival of ≥ 3 months;
. Patient received apatinib treatment regimen at investigators' discretion;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety, which was assessed by recording the incidence and severity of adverse events
Timeframe: between first dose of apatinib and up to 30 days after the last dose of apatinib
. Patient has to voluntarily join the study and sign the Informed Consent Form for the study;
Exclusion criteria
. Subjects with uncontrolled arterial hypertension (systolic blood pressure\> 140 mmHg and diastolic blood pressure \> 90 mm Hg) despite standard medical management; Grade ≥ 2 coronary heart disease; Grade ≥ 2 arrhythmia (including QT interval prolongation, for man \> 450 ms, for woman \> 470 ms), as well as Grade ≥ 2 cardiac dysfunction;
. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
. Subjects with high gastrointestinal bleeding risk, including the following conditions: presence of active ulceration combined with a positive fecal occult blood test (++);history of hematemesis and melena within three months before enrollment; unresected primary lesion in stomach with positive fecal occult blood test (+), ulcerated gastric carcinoma with massive alimentary tract bleeding risk judged by PIs based on gastric endoscopy finding;
. Abnormal coagulation (INR\>1.5、APTT\>1.5 UNL), with tendency of bleeding;
. Presence of central nervous system metastases;
. Pregnant or lactating women;
. Other conditions regimented at investigators' discretion.