A Clinical Study of AL2846 Capsule Combined With Gemzar Injection in the Treatment of Advanced Pancreatic Cancer

Inclusion criteria

• Non operative patients with pancreatic cancer confirmed by histology or cytology, At least one evaluable lesion exists.
• ≥18 years old and ≤70 years old, Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1, expected survival period of more than 3 months.
• No chemotherapy or targeted treatment has been carried out for advanced pancreatic cancer, or more than half a year after the end of postoperative treatment.
• Normal function of major organs.
• Female subjects should agree to use contraception during the study period and within 6 months after the end of the study; Within 7 days prior to enrollment in the study, the serum or urine pregnancy test should be negative and must be a non lactating patient; Male subjects should agree to use contraceptive measures during the study period and within 6 months after the end of the study period.
• Subjects voluntarily participate in this study and sign informed consent.

Exclusion criteria

• Have any type of active malignant tumor or have a history of malignant tumor.
• Previously treated with Gemzar injection.
• Known brain metastases, spinal cord compression, cancerous meningitis, or diseases of the brain or pia mater detected during Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) screening.
• Clinically significant ascites in patients.
• Diarrhea greater than or equal to level 2.
• Have any acute or chronic active infectious disease.
• Hypertensive patients who cannot be well controlled, or suffering from myocardial ischemia or myocardial infarction, arrhythmia, and grade I heart failure.
• Urine routine indicates urine protein ≥++, and it is confirmed that the 24-hour urine protein quantification is greater than 1.0 g.
• History of abdominal fistula, gastrointestinal perforation, or abdominal abscess within 6 months.
• Long term unhealed wounds or fractures.
• Individuals who have experienced arterial/venous thrombosis events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis, and pulmonary embolism.
• Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues; Under the premise that international normalized ratio (INR) is ≤ 1.5, it is allowed to use low-dose warfarin (1mg orally, once daily) or low-dose aspirin (not exceeding 100mg daily) for preventive purposes.
• Individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders.
• Patients known to be allergic to Gemzar injection.
• Patients with active hepatitis B or hepatitis C.
• Individuals with a history of immunodeficiency, including HIV testing positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
• According to the investigator's judgment, there are accompanying diseases that seriously endanger patient safety or affect the completion of the study.