Gastric Cancer Clinical Trial
Official title:
An Open-label, Single Arm Study to Evaluate the Efficacy and Safety of Trastuzumab in Combination With Capecitabine and Oxaliplatin (XELOX) as a First-line Chemotherapy for Inoperable, Locally Advanced or Recurrent and/or Metastatic Gastric Cancer
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
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