Evaluating the efficacy and safety of treatment with Tislelizumab in combination with S-1 in patients with high-risk recurrent intrahepatic cholangiocarcinoma after radical surgery
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Tislelizumab:200mg q3w iv , lasts for one year. S-1:40mg, 50mg, or 60mg orally twice daily for 4 weeks, depending on body surface area, followed by 2 weeks of rest,lasts four cycles.
No.2 People's Hospital of Fuyang city
Fuyang, Anhui, China
RECRUITINGAnhui province hospital
Hefei, Anhui, China
RECRUITING1-year RFS rate
Proportion of patients with no local, regional, or metastatic ICC or death from any cause (whichever occurs first) 12 months after hepatectomy.
Time frame: 12 months
RFS
Time from hepatectomy to the first documented occurrence of local, regional, or metastatic ICC or death from any cause, whichever occurs first.
Time frame: 24 months
OS
Time from hepatectomy to first recorded occurrence of death from any cause
Time frame: 24 months
Survival time after recurrence
The time from the first documented occurrence of localized, regional, or metastatic ICC, whichever occurs first, to death from any cause.
Time frame: 24 months
AEs AEs AEs AEs AE
Adverse Events (AEs)The grade of AEs and the number of patients with AEs are assessed based on CTCAE v5.0
Time frame: 24 months
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