NCT05557578

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

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.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Tislelizumab combined with GEMOX (GOT) regimen	Tislelizumab 200mg on day 1；Gemcitabine 1000mg/m2 on day 1、8；Oxaliplatin 135mg/m2 on day 1；cycle 3 weeks

Timeline

• Start date: 2023-05-05
• Primary completion: 2025-11-30
• Completion: 2025-12-01
• First posted: 2022-09-28
• Last updated: 2025-02-11

Locations

2 sites across 1 country: China