Tislelizumab Combined With Nab-paclitaxel and Gemcitabine for Recurrent Pancreatic Cancer

• Status: Recruiting
• Trial end date: 2023-11-20
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Changhai Hospital
• Treatments: Gemcitabine; Paclitaxel

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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