Although the overall incidence of gastric cancer has steadily declined in many Western countries during the last few decades, it is still one of the most common tumors in China. It is now well recognised that combination chemotherapy regimens improve patient outcomes, but there is no accepted global standard regimen for advanced gastric cancer. The ToGA study was the first randomized, prospective, multicenter, phase III trial to show the efficacy and safety of Trastuzumab in HER2- positive GC. Trastuzumab reduced the risk of death by 26% (HR 0.74; 95% CI 0∙60, 0∙91; p=0∙0046) when combined with a reference chemotherapy (Capecitabine plus Cisplatin) and prolonged the median survival by nearly 3 months (from 11.1 to 13.8 months) in patients with HER2-positive(FISH+ or IHC3+) advanced GC. Oxaliplatin has been shown to be as effective as cisplatin, and exhibits a favorable toxicity profile with a substantially lower rate of nephrotoxicity, ototoxicity, and myelosuppression. In the current study, the efficacy and safety of Trastuzumab in combination with Oxaliplatin/capecitabine chemotherapy will be evaluated in Chinese patients with HER2 positive advanced or recurrent gastric cancer.
Trastuzumab will be administered at a loading dose of 8 mg/kg (on day 1) followed by 6mg/kg i.v. infusion every 3 weeks. Trastuzumab is to be continued until disease progression or intolerable toxicity. Capecitabine (Xeloda) 2000mg/m2d, d1-14; q3w, until disease progression or intolerable toxicity. Oxaliplatin 130mg/m2 d1; q3w, 6 cycles
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Trastuzumab will be administered at a loading dose of 8 mg/kg (on day 1) followed by 6mg/kg i.v. infusion every 3 weeks. Capecitabine 2000mg/m2d, d1-14; q3w, Trastuzumab and capecitabine are to be continued until disease progression or intolerable toxicity. Oxaliplatin 130mg/m2 d1; q3w, 6 cycles
Lin Shen
Beijing, Beijing Municipality, China
Objective response rate
CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation
Time frame: 6 -8 weeks
progression free survival
the follow-up visit of PFS will be performed every 6 weeks
Time frame: 1 year
overall survival of participants
OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 3 months till death or lost
Time frame: 2 years
adverse events
participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Time frame: during the treatment in the hosptital,an expected average of 3 weeks
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