exploring the efficacy and safety of tislelizumab in combination with s-1 in the treatment of patients with postoperative recurrent high-risk intrahepatic cholangiocarcinoma

Conditions: Intrahepatic Cholangiocarcinoma

Summary: 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


Eligibility criteria:
inclusion criteria: * 18-75 years old, male and female; * intrahepatic cholangiocarcinoma was pathologically confirmed after r0 or r1 resection. patients were also pathologically confirmed to have one of the following high-risk factors (i.e., positive margins, multiple tumor nodes, positive lymph nodes, positive perineural infiltration, intrahepatic cholangiocarcinoma \>5 cm in diameter, and combined vascular invasion); * enhanced computed tomography (ct) scans of the chest, abdomen, and pelvis were required within 30 days prior to surgery to demonstrate the absence of distant tumor metastases; * no history of any chemotherapy, radiotherapy, immunotherapy or interventional therapy within 3 months prior to surgical resection; * child-pugh grade a or b, ecog score 0-1; * normal organ function prior to drug administration: anc ≥1.5×10\^9/l, hemoglobin ≥90g/l, plt \>50\*10\^9/l, serum creatinine (scr) ≤ 1.5 times the upper limit of normal (uln) or creatinine clearance ≥50 ml/min (cockcroft-gault formula); total bilirubin (tbil) ≤2 times the upper limit of normal (uln); glutamine transaminase (ast) or glutamine transaminase (alt) levels ≤3 times the uln; urinary protein \<2+ (if urinary protein) upper limit of normal (uln); albumin transaminase (ast) or alanine transaminase (alt) levels ≤3 times upper limit of normal (uln); urine protein \<2+ (if urine protein ≥2+, 24-hour urine protein quantification must show ≤1g of protein); and adequate surgical biliary drainage with no signs of infection. * normal coagulation function: a. international normalized ratio inr ≤ 1.5 x uln; b. partial thromboplastin time aptt ≤ 1.5 x uln; c. prothrombin time pt ≤ 1.5 uln; * in case of hepatitis b virus (hbv) infection: if hbsag-positive, hbv-dna testing is required and hbv-dna must be \<2000 iu/ml and willing to receive antiviral therapy throughout the study period; hepatitis c virus (hcv)-rna-positive patients must have hcv-rna \<1×10\^3copy/ml and must receive antiviral therapy according to treatment guidelines. * no major abnormalities in heart, lung or kidney function; * no history of gastrointestinal hemorrhage; * sign the informed consent form. exclusion criteria: * the tumor is not completely resected, or the pathological diagnosis suggests non-intrahepatic cholangiocarcinoma such as hepatocellular carcinoma, mixed hepatocellular carcinoma, and hepatoportal cholangiocarcinoma; * pregnant or breastfeeding women; * combined with other malignant tumors; * have any active autoimmune disease or a history of autoimmune disease; * uncontrolled clinically significant cardiac disease, including but not limited to the following: (1) \> nyha ii congestive heart failure; (2) unstable angina pectoris; (3) myocardial infarction within the last 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention; * the patient has a congenital or acquired immunodeficiency; * uncontrollable infection \> grade 2 (nci-ctc version 5.0); * psychopaths; * patients have participated in other clinical trials within the past three months; * postoperative patients receiving other targeted agents, immunotherapy such as pd-1 antibodies, and folfox systemic chemotherapy; * patients who are not suitable to participate in the study as determined by the investigator.