This is an open-label,single center,non-randomized,single arm exploratory study. The objective of this study is to evaluate the efficacy and safety of PD-1 antibody plus GEMOX as postoperative adjuvant therapy in perihilar cholangiocarcinoma with positively metastatic lymph nodes.
For perihilar cholangiocarcinoma, radical surgical treatment, such as major hepatectomy combined with total caudate lobe and extrahepatic bile duct resection, remain the potential modality for cure. However, the lymph node tumor metastasis is an independent risk factor for prognosis after radical resection for this disease without distant metastasis. As reported by Nagoya University, Japan, the patients without lymph node tumor metastasis, the 5-year survival rate could reach as high as 67.1% after R0 resection, but the 5-year survival rate was only 22.1% for the patients with lymph node tumor metastasis after R0 resection. Thus, it is urgent to look for an effective adjuvant therapy treatment for these patients with lymph node tumor metastasis. Fluoropyrimidine-based or gemcitabine-based chemotherapy was recommended for these patients by NCCN guidelines. Studies have shown that Gemox chemotherapy (oxaliplatin + gemcitabine) in patients with resected biliary tract cancer has a good benefit in overall survival. However, for extrahepatic cholangiocarcinoma with lymph nodes metastasis, the benefit was limited. In recent years, immunotherapy, such as PD-1 or PD-L1 monoclonal antibody, combined with chemotherapy have shown better results in the palliative treatment of un-resectable biliary tract tumor. However, there is no report on combined immunotherapy with chemotherapy as adjuvant therapy in perihilar cholangiocarcinoma with lymph node tumor metastasis after R0 resection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
62
1. PD-1 antibody,200mg,D1,intravenous infusion, the administration time is 60 (+15) minutes. 2. GEMOX chemotherapy : gemcitabine 1000mg/m2,D1,D8;oxaliplatin 100mg/m2,D1,intravenous infusion. 3. Three weeks is a course of treatment,a total of 6-8 courses.
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGThe 12-month relapse-free survival rate
Relapse-free survival rate in perihilar cholangiocarcinoma with positively metastatic lymph nodes.
Time frame: 12 months
The 12-month overall survival rate
Overall survival rate in perihilar cholangiocarcinoma with positively metastatic lymph nodes.
Time frame: 12 months
The 60-month overall survival rate
Overall survival rate in perihilar cholangiocarcinoma with positively metastatic lymph nodes.
Time frame: 60 months
Relapse-free survival
RFS is defined as the time from resection to relapse or death from any cause, whichever occurred first.
Time frame: 60 months
Overall survival
OS is defined as the time from resection to death from any cause.
Time frame: 60 months
Percentage of participants with adverse events (AEs)
Number of participants who experienced an adverse event (AE)
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.