Neoadjuvant HRS-4642 Plus Chemotherapy With or Without Immunotherapy for Pancreatic Cancer

Prior treatment

• Prior receipt of any anti-tumor therapy, including but not limited to systemic chemotherapy, radiotherapy, interventional therapy, immunotherapy, targeted therapy, and anti-tumor traditional Chinese medicine therapy;
• Known hypersensitivity to the investigational drug or any of its excipients;
• Participation in any interventional clinical trial involving drugs or medical devices within 4 weeks prior to the first administration of study treatment;
• Vaccination with live or live-attenuated vaccines within 4 weeks prior to the first dose of the investigational drug;

Other illness

• Presence of any serious or uncontrolled systemic disease;
• History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
• Any other condition that, in the judgment of the investigator, makes the subject unsuitable for enrollment.

Other

• Presence of distant metastatic lesions confirmed by imaging;
• Clinically significant acute or chronic pancreatitis;

• Male and female participants aged 18-70 (including those who are 18 and 70 years old)；
• Pathologically or cytologically confirmed ductal adenocarcinoma of the pancreas; and subjects must have at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1);
• Life expectancy ≥ 12 weeks;
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
• Adequate marrow and organ function;