drugset / Trial / NCT05557578

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

NCT05557578 ↗

Phase 2 Recruiting 20 enrolled Zhejiang Cancer Hospital
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2023-05-05
Primary completion
2025-11-30
Completion
2025-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule 1000 mg/m2 —
Subject Oxaliplatin Small molecule 135 mg/m2 —
Subject Tislelizumab Monoclonal antibody 200 mg —