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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Tislelizumab 200mg on day 1;Gemcitabine 1000mg/m2 on day 1、8;Oxaliplatin 135mg/m2 on day 1;cycle 3 weeks
1# Banshan East Rd. Zhejiang cancer hospital
Hangzhou, Zhejiang, China
NOT_YET_RECRUITINGJia Wu
Hanzhou, Zhejiang, China
RECRUITINGObjective response rate (ORR)
The proportion of patients who achieved complete response (CR) and partial response(PR) after GOT regimen neoadjuvant treatment according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Time frame: Up to 6 cycle treatment (each cycle is 21 days), an average of 18 weeks.
R0 resection rate
The proportion of patients who achieved pathological negative surgical margin after GOT regimen neoadjuvant treatment.
Time frame: Up to pathological report come out, an average of 20 weeks.
Disease control rate (DCR)
The proportion of patients who achieved complete response (CR), partial response (PR) and stable disease (SD) after GOT regimen neoadjuvant treatment according to RECIST v1.1.
Time frame: Up to 6 cycle treatment (each cycle is 21 days), an average of 18 weeks.
Recurrence free survival
The time between the date of patients underwent radical resection and the date of radiographic recurrence as defined by RECIST1.1.
Time frame: From date when patients are received radical resection until the date of first documented recurrence radiologically, assessed at least 12 months.
Overall survival
The time between the date of patients underwent radical resection and death from any cause.
Time frame: From date when patients are received radical resection until the date of death from any cause, assessed at least 12 months.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.