Gemcitabine and Albumin-Bound Paclitaxel Combined With Liposomal Irenotecan (II) With or Without SHR-1701 as Neoadjuvant Therapy for Resectable or Borderline Resectable Pancreatic Cancer

Korábbi kezelés

• Symptomatic ascites requiring paracentesis or drainage, or patients who have received ascites drainage within the past 3 months (except for those with asymptomatic, controllable minimal ascites detected solely on imaging);
• Malignancy other than pancreatic cancer within 5 years prior to randomization, with the exception of adequately treated cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin；

Más betegség

• Severe gastrointestinal dysfunction (e.g., GI bleeding, obstruction, Grade >2 inflammation, or Grade > 1 diarrhea);
• Current interstitial lung disease (ILD) or pneumonitis;
• Coagulation dysfunction, bleeding tendency, or current thrombolytic or full-dose anticoagulant therapy.
• Uncontrolled clinical cardiovascular symptoms or diseases；
• Known hypersensitivity to liposomal irinotecan, other liposomal formulations, gemcitabine, nab-paclitaxel, retlirafusp alfa injection, or any component of these products；
• Known Acquired Immunodeficiency Syndrome (AIDS), positive HIV antibody test, or active syphilis infection；
• History of neurological or psychiatric disorders, including epilepsy or dementia

Egyéb

• Patients with pancreatic tumors originating from non-pancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, pancreatic acinar cell carcinoma, pancreatoblastoma, and solid-pseudopapillary neoplasm
• Known central nervous system (CNS) metastases
• Known peripheral neuropathy (CTCAE Grade ≥3);

• Age ≥18 years, male or female;
• Resectable or borderline resectable pancreatic cancer
• No prior anti-tumor therapy (including radiotherapy, ablation, chemotherapy, targeted therapy, immunotherapy, etc.) or investigational drug treatment
• At least one measurable lesion as a target lesion according to RECIST v1.1 criteria
• ECOG performance status: 0-1
• Expected survival time ≥3 months
• Adequate major organ function