1. Evaluation of adebelimab in combination with irinotecan liposomes, oxaliplatin, fluorouracil, efficacy and safety of leucovorin in the first-line treatment of advanced metastatic pancreatic cancer 2. Construct the model of immunotherapy combined with chemotherapy for the treatment of pancreatic cancer liver metastasis
Patients voluntarily join this study and sign the informed consent form
Age: 18-75 years old (inclusive), male or female
Histologically confirmed pancreatic cancer liver metastases and no previous treatment of any systemic anti-swelling tumor treatment
No central nervous system metastases
Other active malignancies within 5 years or concomitantly
Have uncontrolled cardiac clinical symptoms or diseases, such as: (1) in accordance with: New York Heart Association (NYHA) criteria grade II or greater cardiac insufficiency or Cardiac ultrasonography: LVEF (left ventricular ejection fraction) <50%; (2) Instability Stereotyped angina; (3) Myocardial infarction within 1 year prior to the start of study treatment Die; (4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention: (5) QTc>450ms (male); QTc>470ms (Women) (The QTc interval is calculated by Fridericia's formula; If the QTc is abnormal, interval can be used Approximately 2 minutes for three consecutive tests, taking the average);
Those who have high blood pressure and cannot be reduced to the normal range by antihypertensive drug treatment (admitted Systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg) (based on 2 measurements of ≥ The mean of the BP readings obtained), which is allowed to be achieved through the use of antihypertensive therapy above parameters
Coagulation abnormalities (INR>1.5×ULN, APTT>1.5×ULN), with: Bleeding tendency
Single group
Irinotecan liposome
Drug* Patients are planned to receive irinotecan liposomal (60 mg/m2; d1) of every cycle. * 27 days a cycle
Adebrelimab
Drug* Patients are planned to receive Adebrelimab (20 mg/kg; d1) of every cycle. * 27 days a cycle
Oxaliplatin
Drug* Patients are planned to receive Oxaliplatin (85 mg/m2; d1) of every cycle. * 27 days a cycle
Fluorouracil
Drug* Patients are planned to receive fluorouracil (2400mg/m2; d1) of every cycle. * 27 days a cycle
Calcium folinate
Drug* Patients are planned to receive Calcium folinate (400mg/m2; d1) of every cycle. * 27 days a cycle
ORR
The proportion of patients whose tumors shrink to a certain amount for a certain period of time and include cases of complete response (CR) and partial response (PR). Calculated as: (CR cases + PR cases) / FAS × 100 (%); FAS (full analysis set) refers to the case of qualified patients, administered more than one case. Tumor remission rates are calculated according to the RECIST guidelines (version 1.1)
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Jiang Long
Lead sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor institution