Prospective Exploratory Study of Tislelizumab Combined With Nab-paclitaxel and Gemcitabine for Postoperative Recurrence of Pancreatic Cancer

Trial ID: NCT04902261

Interventional - Phase 2 - Unknown status

To evaluate the efficacy of Tislelizumab combined with Nab-paclitaxel and Gemcitabine in the treatment of recurrent pancreatic cancer

Conditions

- Patients with radiologically or histologically confirmed postoperative Recurrent Pancreatic Cancer
Patients with at least one measurable lesion (according to RECIST 1.1 criteria);
Have not received gemcitabine-based regimen after surgery
No systemic treatment after diagnosis of recurrence
ECOG score 0-1
Expected survival ≥ 3 months;
Liver function is essentially normal: absolute neutrophil count > 1500/mm ³; platelet count > 100,000/mm ³; creatinine less than 1.5 times the upper limit of normal or calculated creatinine clearance (CRCI) > 45 mL/min; total bilirubin ≤ 2.0 mg/dL; aspartate aminotransferase (AST) and alanine aminotransferase less than 2.5 times the upper limit of normal
Appropriate to participate in this trial as assessed by the investigator before entering the study
Male and female subjects of childbearing potential must agree to use an effective method of contraception throughout the study
Signed Informed Consent Form

- Patients who only undergo abdominal laparotomy but do not undergo resection of pancreatic tumor tissue
Received gemcitabine-based regimen after surgery
Systemic treatment after diagnosis of recurrence
Patients with previous allergic reactions to similar drugs
Pregnant or lactating patients
Presence of pericardial effusion, uncontrolled pleural effusion, or clinically significant ascites at screening (including detectable ascites or ascites requiring puncture and aspiration on physical examination at screening)
History of interstitial lung disease, pneumonitis, or uncontrolled systemic disease, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc
Patients with severe cardiovascular diseases within 12 months before enrollment, such as symptomatic coronary heart disease, ≥ grade II congestive heart failure, uncontrolled arrhythmia, myocardial infarction, etc
Presence of any active immunodeficiency or autoimmune disease and/or history of any immunodeficiency or autoimmune disease that may recur at screening (e.g., hypothyroidism or hyperthyroidism, interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, etc)
Use of steroids or other systemic immunosuppressive therapy 14 days prior to enrollment
Patients with other previous malignancies who are not cured
Immunodeficient patients, such as HIV-positive
Uncontrollable psychosis

Changhai Hospital