An Open-label, Randomized, Multi-center, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Immuncell-LC Therapy Combined With Gemcitabine Versus Adjuvant Gemcitabine Single Therapy After Resection in Patients With Pancreatic Ductal Adenocarcinoma
PURPOSE: This phase III clinical trial evaluates the efficacy and safety of adjuvant Immuncell-LC therapy combined with gemcitabine versus adjuvant gemcitabine single therapy after R0 or R1 resection in patients with pancreatic ductal adenocarcinoma.
• Age \>/=20 years old, \</=80 years old.
• Histologically or cytologically confirmed pancreatic ductal adenocarcinoma that fulfill the following requirements:
‣ Participants have undergone a radical full resection (R0) or boundary resection (R1) operation and has elapsed at least two weeks after the resection based on the baseline, up to 12 weeks.
⁃ Noncancerous ascites.
⁃ No evidence of distant metastasis (such as liver, peritoneum)
⁃ No evidence of distant metastasis in other distant abdominal or extra-abdominal organs
⁃ Scheduled to be given gemcitabine alone as postoperative adjuvant chemotherapy
• Eastern Cooperative Oncology Group-performance status (ECOG-PS) 0 - 2
• Life expectancy is at least 12 weeks.
• Adequate organ and marrow function at the screening and baseline as defined below:
‣ Absolute neutrophil count ≥ 1,500/μL
⁃ Hemoglobin level ≥ 9 g/dL
⁃ Platelet count ≥ 100,000/μL
⁃ BUN, serum creatinine ≤ 1.5 × institutional upper limit of normal (ULN)
⁃ AST, ALT ≤ 2.5 × institutional upper limit of normal (ULN)
⁃ PT (INR), activated partial thromboplastin time (aPTT) ≤ 1.5 × institutional upper limit of normal (ULN)
• Ability to understand and the willingness to sign a written informed consent document.