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

Summary

To evaluate the safety and efficacy of HRS-4642 in Combination With AG and Adebrelimab for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer

Eligibility

Inclusion Criteria:

1. Age: ≥18 and ≤80 years old, male or female;
2. Pathologically or cytologically confirmed ductal adenocarcinoma of the pancreas; and subjects must have at least one measurable lesion as defined by RECIST v1.1;
3. Imaging evaluation met the NCCN guidelines definition of resectable pancreatic cancer (including high-risk resectable) and borderline resectable pancreatic cancer.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
5. Life expectancy ≥ 12 weeks;
6. Adequate marrow and organ function;
7. 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;
8. Patients volunteered to participate in this study and signed informed consent;

Exclusion Criteria:

1. Previously received any anti-tumor therapy;
2. the presence of distant metastatic lesions diagnosed by imaging;
3. Known hypersensitivity to the study drug or any of its components;
4. previous or concurrent other malignant tumors;
5. Participation in a clinical trial of any drug or medical device within 4 weeks prior to the first dose;
6. Received live and attenuated vaccines within 4 weeks prior to the first dose of the investigational drug;
7. previous allogeneic hematopoietic stem cell transplantation or organ transplantation;
8. 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;
9. 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);
10. 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;
11. 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);
12. 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);
13. 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
14. Other situations that the researcher felt should not be included.

Conditions2

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