Clinical Trial of Autologous Tcm Cellular Immunotherapy Combined With Traditional Therapy in Intrahepatic Cholangiocarcinoma Patients After Radical Resection
The prime purpose of this trial is to evaluate the Progression Free survival and two-year survival of combining autologous Tcm cellular immunotherapy and traditional therapy in intrahepatic cholangiocarcinoma (ICC) patients after radical resection. A secondary objective of the trial is to assess the long-term survival and safety of Tcm cellular immunotherapy and traditional therapy in ICC patients after radical resection. Patients will be randomized 1:1 either to the experimental group to receive autologous Tcm cellular immunotherapy and chemotherapy or to the control group (traditional therapy).
• Be willing and able to provide written informed consent for the trial
• Subjects treated with radical resection completely, and pathologically confirmed intrahepatic cholangiocarcinoma
• Subjects with image examination confirmed complete response (CR) postoperatively
• Age between 18 and 70 years old
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Normal hematopoietic function:
• White Blood Cell (WBC) ≥ 4×10\^9 /L Neutrophil ≥ 2×10\^9 /L Hemoglobin ≥ 90 g /L Platelets ≥ 100×10\^9 /L
• Lymphocyte ≥ 0.7×10\^9 /L
• Adequate Liver and kidney function Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 the upper limit of normal (ULN) for the institution Total bilirubin (TBIL) ≤ 1.5 the upper limit of ULN Serum creatinine (CREA) ≤ 1.5 the upper limit of ULN Creatinine clearance ≥ 70 ml/min
• Subjects without significant cardiovascular and lung disease