resectable or borderline resectable pancreatic cancer
Conditions
Interventions
Experimental group:AG (albumin paclitaxel plus gemcitabine) regimen chemotherapy combined with tislelizumab plus regorafenib combined with granulocyt-macrophage colony colony
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically and/or cytologically confirmed pancreatic ductal adenocarcinoma. 2. Patients who need neoadjuvant therapy according to guidelines, including: (1)Patients with critically resectable pancreatic cancer as defined by NCCN guidelines 2020; (2)Resectable pancreatic cancer with risk factors described in guidelines for comprehensive diagnosis and treatment of pancreatic cancer (2018) and Chinese guidelines for neoadjuvant therapy of pancreatic cancer (2020), including: 1)High serum CA19-9, ca19-9 >210 U/ml; 2)Large primary pancreatic tumors, with the maximum diameter of the primary tumor >3.0 cm; 3)The maximum diameter of regional lymph nodes >1.0 cm; 4)Patients with preoperative serological characteristics of "abnormal increase of CEA, abnormal increase of CA125, and CA19-9>=1 000 U/ml". 3.Aged 18 to 75 years, gender is not limited; 4.Expected survival >=3 months; 5.ECOG score 0-1; 6.At least 1 measurable lesion according to RECIST 1.1 criteria. 7.No previous chemotherapy or PD-1/PD-L1 mab treatment. 8.The function of major organs is good, that is, relevant examination indexes within 14 days before enrollment meet the following requirements: (1)Hemoglobin >= 90 g/L (no blood transfusion within 14 days); (2)Neutrophil count > 1.5x10^9/L; (3)Platelet count >= 100x10^9/L; (4)Total bilirubin =60 mL /min (Cockcroft-Gault formula); (7)Cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= 50%. 9.The informed consent was signed and the compliance was good, and the family members agreed to cooperate with the survival follow-up.
Exclusion criteria
Exclusion criteria: 1.Except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; Patients with tumors such as small gastric stromal tumors and other early-stage tumors that the researchers determined would not affect the patient's life in the short term after radical treatment were excluded. 2.Participate in other drug clinical trials within four weeks; 3.Patients with known or history of CENTRAL nervous system metastasis prior to screening. For patients with clinically suspected central nervous system metastasis, CT or MRI examination must be performed within 28 days before enrollment to exclude central nervous system metastasis; 4.Patients with a history of unstable angina; Newly diagnosed angina pectoris within 3 months prior to screening or myocardial infarction within 6 months prior to screening; Arrhythmias (including QTcF: >=450 ms for men and >=470 ms for women) require long-term use of antiarrhythmic drugs and New York Heart Association grade >=II cardiac dysfunction; 5.Urine routine examination indicated urinary protein >=++ and confirmed 24-hour urinary protein quantification >1.0 g; 6.For female subjects: should be surgically sterilized, postmenopausal, or agree to use a medically approved contraceptive during the study period and for 6 months after the end of the study period; Serum or urine pregnancy tests must be negative within 7 days prior to study enrollment and must be non-lactation. Male subjects: patients who should be surgically sterilized or who have agreed to use a medically approved contraceptive method during the study period and for 6 months after the end of the study period; 7.Previous use of immunotargeted therapy drugs; 8.A history of immune deficiency or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 9.Patients with infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and other patients requiring corticosteroids; 10.A history of chronic autoimmune diseases, such as systemic lupus erythematosus; Have a history of ulcerative enteritis, crohn's disease and other inflammatory bowel disease, have a history of chronic diarrhoeal diseases such as irritable bowel syndrome; A history of sarcoidosis or tuberculosis; Patients with an active history of hepatitis B, hepatitis C and HIV infection; 11.Patients with high sensitivity to human or mouse monoclonal antibodies; 12.Has a history of abuse of psychotropic substances and cannot quit or has mental disorders; 13.Pleural effusion or abdominal effusion with clinical symptoms that require clinical intervention; 14.Concomitant disease that, in the investigator's judgment, seriously endangers patient safety or interferes with patient completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Major pathological response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Overall survival;Safety;Progression-free survival; | — |
Countries
China
Contacts
Public ContactLi Wei
The First Affiliated Hospital of Soochow University
Outcome results
None listed