Status:
UNKNOWN
Tislelizumab Combined With Nab-paclitaxel and Gemcitabine for Recurrent Pancreatic Cancer
Lead Sponsor:
Changhai Hospital
Conditions:
Recurrent Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To evaluate the efficacy of Tislelizumab combined with Nab-paclitaxel and Gemcitabine in the treatment of recurrent pancreatic cancer
Detailed Description
There is heterogeneity in desmoplasia between different metastatic sites in pancreatic cancer. The tumor quasi-characteristics of patients with metastatic PDAC at presentation were more obvious than t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 20 2023
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04902261
Start Date
November 20 2020
End Date
November 20 2023
Last Update
September 1 2023
Active Locations (1)
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1
Changhai Hospital
Shanghai, China, 200433