Nano-Megestrol Acetate for Cancer Cachexia in Advanced Pancreatic Cancer

Exclusion criteria

• . Active or untreated CNS metastases (e.g., brain or leptomeningeal metastases) as determined by CT or magnetic resonance imaging (MRI) during screening or based on prior imaging assessments. Patients with previously treated brain or leptomeningeal metastases may be eligible if the disease has been stable for ≥ 2 months and systemic corticosteroid therapy (\>10 mg/day prednisone or equivalent) has been discontinued for \> 4 weeks prior to randomization.
• . Uncontrolled tumor-related pain;
• . Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;
• . Patients with hepatitis B or hepatitis C:
• . Patients with a positive test result for human immunodeficiency virus (HIV);
• . Major surgery (excluding diagnostic procedures) within 28 days prior to randomization, or anticipated major surgery during the study period;
• . Significant cardiovascular disease, such as heart disease defined as New York Heart Association class II or higher, myocardial infarction within 3 months prior to randomization, unstable arrhythmia, unstable angina, cerebrovascular accident, or transient ischemic attack. Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction \< 50% must be receiving optimal stable therapy as determined by the treating physician; consultation with a cardiologist may be obtained if necessary;
• . Severe infection occurring within 4 weeks prior to first dosing, including but not limited to infections with complications requiring hospitalization, sepsis, or severe pneumonia; or active infection requiring systemic anti-infective therapy within 2 weeks prior to first dosing (excluding antiviral therapy for hepatitis B or C).