Status and phase
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About
This trial is a multicenter, randomized, controlled phase Ш clinical study of comparison of Docetaxel for Injection (Albumin-bound) and Taxotere in locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma with previous first-line treatment failure.
Full description
About 630 patients with locally advanced or metastatic gastric adenocarcinoma or gastric esophageal junction adenocarcinoma will be randomly assigned to the test group or the control group. All patients will receive Docetaxel for injection (Albumin-bound) or Taxotere for treatment until disease progression. Regular visits and imaging examinations will be conducted to compare the efficacy and safety of the two groups.
Enrollment
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Inclusion criteria
Exclusion criteria
History of serious cardiovascular or cerebrovascular disease, including but not limited to:
Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, third degree atrioventricular block, etc;
Acute coronary syndrome, congestive heart failure, stroke, or other level 3 or higher cardiovascular events occurring within 6 months before randomization;
The New York Heart Association (NYHA) heart function rating of ≥ Grade Ⅱ or left ventricular ejection fraction (LVEF) of<50%;
Long QTc syndrome or QTc interval>480 milliseconds, as well as the use of any known concomitant medication that can prolong the QT interval;
Poor control of hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg during the screening period).
Primary purpose
Allocation
Interventional model
Masking
630 participants in 2 patient groups
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Central trial contact
Clinical Trials Information Group officer
Data sourced from clinicaltrials.gov
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