OncoMatch/Clinical Trials/NCT05557578
GOT Applied As Neoadjuvant Regimen for Patients of Resectable ICC with High-risk Factors of Recurrence
Is NCT05557578 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Tislelizumab combined with GEMOX (GOT) regimen for intrahepatic cholangiocarcinoma.
Treatment: Tislelizumab combined with GEMOX (GOT) regimen — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–0(Fully active)
Prior therapy
Cannot have received: systemic therapy
never received systemic therapy including chemotherapy, immunotherapy, target therapy and other anti-cancer therapy
Cannot have received: radiotherapy
Exception: except for previous non-tumor-related surgeries and diagnostic biopsies
Anti-cancer therapy or surgery such as radiotherapy, radiofrequency ablation, interventions in 28 days prior to the first dose of the study
Cannot have received: radiofrequency ablation
Exception: except for previous non-tumor-related surgeries and diagnostic biopsies
Anti-cancer therapy or surgery such as radiotherapy, radiofrequency ablation, interventions in 28 days prior to the first dose of the study
Cannot have received: interventional therapy
Exception: except for previous non-tumor-related surgeries and diagnostic biopsies
Anti-cancer therapy or surgery such as radiotherapy, radiofrequency ablation, interventions in 28 days prior to the first dose of the study
Lab requirements
Blood counts
haemoglobin ≥90g/L, Neutrophil count ≥1.5×10⁹/L, Platelet count ≥100×10⁹/L
Kidney function
serum creatinine <1.5 ULN; Creatinine clearance ≥60 mL/min
Liver function
Aspartate or alanine aminotransferase ≤5 ULN, alkaline phosphatase ≤2.5 ULN, Serum albumin ≥30g/L
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 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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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