Low-dose RAD001(Everolimus) Plus Cisplatin-HDFL Chemotherapy for the First-line Treatment of Advanced Gastric Cancer

Inclusion Criteria:

1. Patients must have a histologically proven adenocarcinoma of the stomach, with unresectable locally advanced, recurrent or metastatic disease;
2. Patients must receive no prior chemotherapy for unresectable locally advanced, recurrent or metastatic gastric cancer. Previous post-gastrectomy adjuvant therapy should be completed more than 6 months before enrollment;
3. Patients must have at least one "measurable" lesion (by RECIST);
4. Patients must have adequate baseline organ functions, and fasting triglyceride level \>/= 70 mg/mL;
5. Patients must be younger than 75 years of age;
6. Patients must have an ECOG performance status \</= 2;
7. Patients' life expectancy should be expected \>/= 3 months;
8. Patients must sign an informed consent form.

Exclusion Criteria:

1. Patients who have received radiotherapy, chemotherapy, or other experimental therapy within the previous 4 weeks or who are planning to receive such therapies simultaneously with RAD001 plus P-HDFL;
2. Patients who have known hypersensitivity to everolimus, sirolimus or to its derivative;
3. Patients who should not withdrawal from medication which can induce or inhibit activity of CYP3A4 during study period;
4. Patients who have uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations;
5. Patients with CNS metastasis;
6. Patients who refuse port-A implantation;
7. Women who are currently pregnant or breast feeding, and women of child-bearing potential without adequate contraception;
8. Patients who have another prior malignancy, except for adequately treated basal cell, cervical carcinoma in situ, or any cancer from which the patient has been disease-free for 5 years.