pancreatic cancer
Conditions
Interventions
Intervention Group:gemcitabine + Albumin paclitaxel + Toripalimab monoclonal antibody
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
30 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with borderline resectable or locally advanced pancreatic cancer diagnosed by preoperative imaging; 2. At least one measurable lesion according to RECIST and irRECIST criteria; 3. Puncture biopsy, intraoperative freezing or postoperative pathology confirmed pancreatic ductal adenocarcinoma; 4. Patients who have no comprehension barriers and have signed and agreed to join the study; 5. Physical condition score ECOG 02; 6. The test results within 1 week before enrollment meet the following conditions: neutrophils (ANC) >= 1.5x10^9/L, platelets (PLT) >= 60 x 10^9/L, hemoglobin (HGB) >= 90g/L; Serum creatinine (Cr) = 60 ml/min/1.73m2; total bilirubin (TBI) <= 2 x upper limit of normal (with biliary tract) Obstruction, patients after biliary drainage <= 2.5 x ULN), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) <= 2.5 x upper limit of normal. Thyroid-stimulating hormone (TSH) <= 1 times ULN (if abnormal, T3 and T4 levels should be examined at the same time, if T3 and T4 levels are normal, they can be enrolled); for patients who have not received anticoagulation therapy, the international normalized ratio of prothrombin time (INR ) <= 1.5, partial thromboplastin time (APTT) <=1.5 times the upper limit of normal; serum sodium, potassium, calcium, and magnesium levels <= grade 1 standard (NCI-CTCAE (version 4.0); electrocardiogram showed QTc interval <= 480ms.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of autoimmune diseases; 2. The patient is accompanied by systemic use of corticosteroids or other immunosuppressive hormones; 3. Previous anti-tumor therapy in any form, including intervention, ablation, radiotherapy, chemotherapy, and molecular targeted therapy; 4. Suffered from or associated with other systemic malignant tumors in the past 5 years; 5. Patients with severe heart, brain, liver, kidney, lung and other serious physical diseases; 6. Patients with acute infection or active hepatitis; 7. Pregnant, lactating women, and subjects with reproductive capacity are unwilling to take effective contraceptive measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate; | — |
Countries
China
Contacts
Public ContactGuo Ziheng
West China Hospital of Sichuan University
Outcome results
None listed