Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT00632268
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
75 Years
Study:
NCT00632268
Study Brief:
Protocol Section:
NCT00632268