A randomized, open-label, multicenter Phase IIIb study comparing two trastuzumab dosing regimens, each in combination with cisplatin/ capecitabine chemotherapy, as first-line therapy in patients with HER2-positive metastatic gastric or gastro-esophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.

F.Hoffmann-La Roche Ltd0 个研究点目标入组 406 人开始时间: 2011年9月6日最近更新: 2015年8月31日

适应症

试验速览

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•1. Male or female. Age = 18 years.
•4. Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with metastatic disease documented to involve at least lung or liver or both
•5. Measurable disease according to RECIST 1.1. or non-measurable evaluable disease
•6. At least 2 organs involved by metastatic gastric tumor (including at least lung or liver or both) in addition to the site of the primary tumor. Metastasis in distant lymph nodes, peritoneal metastasis, malignant pleural effusion, etc. count as 'organs' in this context.
•7. HER2 positive (defined as either IHC3+ or IHC2+/ISH+, with ISH positivity defined as a ratio of >=2.0 of HER2 gene copy number/number of signals for CEP 17) primary or metastatic tumor, as assessed by central laboratory
•8. CCR >=45 ml/min
•9. ECOG PS =2
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 263
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 142

•1. Previous chemotherapy for locally advanced or metastatic disease
•2. Prior gastrectomy
•3. Prior therapy with an anti-HER2 agent and/or platinum-based chemotherapeutic agent
•4. Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (e.g., patients with a jejunostomy probe, gastric or jejunostomy tubes) which may impair the ability to administer or absorb capecitabine, as capecitabine is an orally administered drug.
•6. Residual relevant toxicity resulting from previous therapy
•11. History of documented congestive heart failure; angina pectoris requiring medication; electrocardiogram (ECG) evidence of trans-mural myocardial infarction; poorly controlled hypertension (systolic blood pressure (BP) > 180 mmHg or diastolic BP>100 mm Hg); clinically significant valvular heart disease; or high risk uncontrollable arrhythmias
•12. Baseline LVEF< 50%, documented by echocardiography, MUGA scan, or cardiac MRI.

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