RecruitingPhase 2NCT05557578

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.


Sponsor

Zhejiang Cancer Hospital

Enrollment

20 participants

Start Date

May 5, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — gemcitabine/oxaliplatin chemotherapy plus a targeted therapy and immunotherapy — given before surgery in patients with a type of bile duct cancer inside the liver (intrahepatic cholangiocarcinoma, or ICC) that can be removed but has high-risk features for coming back. **You may be eligible if:** - You are between 18 and 75 years old - You have been diagnosed with intrahepatic cholangiocarcinoma (a liver/bile duct cancer) - You have not received any prior cancer treatment - Your tumor is large (over 5 cm), multiple, involves blood vessels, or has features suggesting it may spread - Your liver function and blood counts are adequate - Your cancer is removable by surgery **You may NOT be eligible if:** - You have previously received chemotherapy, immunotherapy, or targeted therapy for this cancer - Your liver function is poor (Child-Pugh class B or C) - Your organs are not healthy enough to tolerate surgery and chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTislelizumab 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


Locations(2)

1# Banshan East Rd. Zhejiang cancer hospital

Hangzhou, Zhejiang, China

Jia Wu

Hanzhou, Zhejiang, China

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NCT05557578


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