Tislelizumab Combined with GEMOX (GOT) Applied As Neoadjuvant Regimen for Patients of Resectable Intrahepatic Cholangiocarcinoma with High-risk Factors of Recurrence: a Single Arm, Single Center, Prospective, Explorative Clinical Trail.
Intrahepatic cholangiocarcinoma (ICC) arises from the epithelial cells of bile ducts and occurs proximal to the segmental biliary ducts. ICC is highly aggressive, long-term survival only can be achieved in patients with R0 surgical resection. Large diameter of tumor, multiple tumors, preoperative carbohydrate antigen(CA)19-9 elevated, tumors invaded adjacent blood vessels and preoperative radiology hints suspected regional lymph node metastasis were considered as high-risk factors of recurrence in the previous study. Chemotherapy can trigger antigen release and induces strong anti-tumor effects of T cells due to cytotoxic cell death. Immune checkpoint inhibitors can relieve tumor immunosuppressive microenvironment. Hence, we aim to investigate objective response rate and R0 resection rate and survival rate of patients with high-risk factors of recurrence who receives Tislelizumab combined with GEMOX regimen(GOT) as a neoadjuvant therapy.
• 18-75 yo;
• Patients of Pathological confirmed intrahepatic cholangiocarcinoma who has never received systemic therapy including chemotherapy, immunotherapy, target therapy and other anti-cancer therapy;
• Patients of resectable ICC with high risk recurrent factors:
• ①Maximum diameter greater than 5cm or multiple tumors.
• ②Preoperative CA19-9 greater than 200 Unit(U)/mL
• ③Tumors invaded adjacent blood vessels
• ④Preoperative radiology hints suspected regional lymph node metastasis.
• ⑤Tumor tissues confirmed by CT or MRI, at least one measurable lesion exists according to RECIST v1.1.
• Eastern Cooperative Oncology Group(ECOG)-Performance status(PS) score is 0 before first drug administration;
• Child-Pugh classification is class A;
• Estimated overall survival is greater than 16 weeks;
• The level of organ function meets the criteria and can tolerate surgery before the first treatment. Main organs meet the criteria as below:
• haemoglobin≥90g/L，Neutrophil count≥1.5×10⁹/L，Platelet count≥100×10⁹/L；Aspartate or alanine aminotransferase≤5 upper limits of normal(ULN），alkaline phosphatase≤2.5 ULN，Serum albumin≥30g/L；serum creatinine\<1.5 ULN；International normalized ratios（INR）≤2 or Prothrombin time（PT）exceed ULN≤6s；Creatinine clearance≥60 mL/min.
• Male and female subjects with potential fertility had to agree to the use of effective contraceptive methods throughout the study period；
• Sign an informed consent form agreeing to provide previously preserved specimens of tumor tissue or fresh detection of tumor lesions.