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

Launched by CHANGHAI HOSPITAL · May 25, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people with recurrent pancreatic cancer, specifically looking at the combination of a drug called Tislelizumab with two other medications, Nab-paclitaxel and Gemcitabine. The goal of the trial is to see how effective this combination is in treating patients whose cancer has come back after surgery. The trial is currently enrolling participants aged 65 to 74, and both men and women can join.

To be eligible for the trial, patients must have had their pancreatic cancer confirmed through imaging or tissue testing and must have at least one measurable tumor. They should not have received any treatment with Gemcitabine after their surgery, and they should not have had any other systemic treatments since their cancer returned. Participants will need to provide informed consent, which means they agree to join the study after understanding what it involves. Throughout the trial, participants will be closely monitored to ensure their safety and health. This study may offer a new option for those looking for additional treatment for their recurrent pancreatic cancer.

Gender

ALL

Eligibility 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