Tislelizumab With Anlotinib and Chemotherapy for Second-line Treatment of Pancreatic Cancer
Pancreatic Neoplasms
About this trial
This is an interventional treatment trial for Pancreatic Neoplasms focused on measuring Advanced, second-line treatment
Eligibility Criteria
Inclusion Criteria: Advanced or metastatic pancreatic adenocarcinoma diagnosed by pathology; Previously received a standard first-line chemotherapy regimen of pancreatic cancer Age ≥ 18 and≤ 75 years old; Expected survival ≥ 3 months; ECOG score 0-1; Child-Pugh score < 8; There is at least one measurable tumor lesion: the long diameter is ≥10 mm, and the short diameter of lymph nodes is ≥15 mm; The results of liver and kidney function and blood routine examination within 1 week before enrollment meet the following conditions: Neutrophils (ANC) ≥ 1.5×109/L, platelets (PLT) ≥ 80×109/L, hemoglobin (HGB) ≥ 80g/L; Serum creatinine (Cr) ≤ 1.5 × upper limit of normal value; total bilirubin (TBIL) ≤ 2.5 × upper limit of normal value, Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤2.5× upper limit of normal value; - The patient voluntarily participated in this study and signed the informed consent form. Exclusion Criteria: Received other immunotherapy previously(including immune checkpoint inhibitor PD-1/PDL1 and other immune checkpoint inhibitors) and/or anti-angiogenic drugs (including anti-VEGFR monoclonal antibody and anti-angiogenic small molecule kinase inhibitors) ; Known to be severely allergic to the drugs used in the study of tislelizumab and anlotinib; Patients with obstructive jaundice who cannot reach TBIL ≤ 2.5 times the upper limit of normal value after surgical intervention; Patients with biliary obstruction that may occur or worsen within 4 to 6 weeks; Obvious blood coagulation disorder, active bleeding and bleeding tendency; There is a history of other malignant tumors within 5 years (adequately treated skin basal cell carcinoma, cervical in situ); Interstitial pneumonia or pulmonary fibrosis; Uncontrollable pleural effusion or ascites; Severe uncontrolled medical diseases, acute infections, recent history of myocardial infarction (within 3 months); During pregnancy or breastfeeding, and those who refuse to take appropriate contraceptive measures during the test; Patients judged by the investigator to be inappropriate to participate in this study.
Sites / Locations
- The First Affiliated Hospital of Xian Jiaotong UniversityRecruiting
Arms of the Study
Arm 1
Experimental
Tislelizumab Combined With Anlotinib and Chemotherapy
Tislelizumab iv drip, every 3 weeks; Anlotinib, oral,once a day; chemotherapy will be choiced by investigator according guildline.