HRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel and Adebrelimab for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer

Korábbi kezelés

• Previously received any anti-tumor therapy;
• previous or concurrent other malignant tumors;
• Participation in a clinical trial of any drug or medical device within 4 weeks prior to the first dose;
• Received live and attenuated vaccines within 4 weeks prior to the first dose of the investigational drug;
• previous allogeneic hematopoietic stem cell transplantation or organ transplantation;
• Systemic treatment with corticosteroids (>10 mg/day of prednisone or other equivalent hormone) or other immunosuppressive agents within 2 weeks prior to the first dose; inhaled or topical corticosteroids and adrenal hormone replacement therapy at doses
  • ≤10 mg/day of prednisone efficacy permitted in the absence of active autoimmune disease

Más betegség

• Known hypersensitivity to the study drug or any of its components;
• Patients with severe cardiovascular arterial thromboembolism (e.g., myocardial infarction, unstable angina, stroke), NYHA class 2 or greater cardiac insufficiency, and clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
• with interstitial lung disease, non-infectious pneumonia or severe and uncontrolled medical illness, acute infections, recent history of major surgery (within 28 days or not yet recovered from side effects);
• with congenital or acquired immunodeficiencies such as human immunodeficiency virus (HIV) infection, active hepatitis B (positive hepatitis B virus surface antigen [HBsAg] test result at screening together with an HBVDNA test value of ≥10,000 copies/ml [2000 IU/ ml]), active hepatitis C (hepatitis C virus antigen [HCV-antibodies] at screening), or active hepatitis C (hepatitis C virus antitoxin [HCVantibodies] at screening).antibody [HCV-Ab] positive at screening and HCV-RNA positive at the same time), or co-infection with hepatitis B and hepatitis C;
• Patients with any active autoimmune disease or history of autoimmune disease (e.g., the following, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, and hyperthyroidism; patients with asthma that has completely resolved in childhood and does not require any intervention in adulthood can be included; patients with asthma that requires medical intervention with bronchodilators cannot be Inclusion);

Laborértékek

• Presence of clinically significant acute or chronic pancreatitis; patients at high risk for pancreatitis, e.g., serum amylase and/or lipase concentrations ≥3 times ULN (except when the investigator determines that abnormally elevated amylase and/or lipase are associated with pancreatic cancer);

Egyéb

• the presence of distant metastatic lesions diagnosed by imaging;
• Other situations that the researcher felt should not be included.

• Age: ≥18 and ≤80 years old, male or female;
• Pathologically or cytologically confirmed ductal adenocarcinoma of the pancreas; and subjects must have at least one measurable lesion as defined by RECIST v1.1;
• Imaging evaluation met the NCCN guidelines definition of resectable pancreatic cancer (including high-risk resectable) and borderline resectable pancreatic cancer.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
• Life expectancy ≥ 12 weeks;
• Adequate marrow and organ function;
• Female participants of childbearing age must undergo a pregnancy test within one week before the start of the study medication, and the result is negative. They are willing to use a medically recognized and efficient contraceptive method during the study period and within three months after the last administration of the study medication; For male participants whose partners are women of childbearing age, they should agree to use effective methods of contraception during the study period and within 6 months after the last study administration;
• Patients volunteered to participate in this study and signed informed consent;