GOT Applied As Neoadjuvant Regimen for Patients of Resectable ICC with High-risk Factors of Recurrence

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.

NCT Number	NCT05557578
Lead Sponsor	Zhejiang Cancer Hospital
Conditions	Intrahepatic Cholangiocarcinoma
Enrollment	20 participants
Start Date	2023-05-05
Primary Completion	2025-11-30 (estimated)
Study Completion	2025-12 (estimated)
Updated on ClinicalTrials.gov	2025-02-11