Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer

Ki vehet részt

• Age ≥ 18 years, male or female; Histopathologically confirmed biliary tract malignancy (intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma, gallbladder cancer, and distal cholangiocarcinoma) and underwent radical surgery with negative surgical margins; No history of other tumors, and no prior anti-tumor therapy (including but not limited to chemotherapy, immunotherapy, radiotherapy, targeted therapy, etc.) before or after surgery; ECOG performance status: 0~1; Baseline blood counts and biochemistry must meet: hemoglobin ≥ 80 g/L; absolute neutrophil count ≥ 1.5 × 10\^9/L; platelet count ≥ 60 × 10\^9/L; ALT/AST ≤ 3 times ULN; total bilirubin ≤ 2 times ULN; serum creatinine ≤ 1.5 times ULN; albumin ≥ 30 g/L; INR < 1.7 or PT prolonged ≤ 4 seconds; Women of childbearing potential must agree to use contraception during the study and for 6 months after; negative pregnancy test within 7 days prior to enrollment; non-lactating. Men must agree to use contraception; Patients with active HBV infection must receive anti-HBV therapy starting from screening and willing to continue; HCV RNA positive patients must receive standard antiviral therapy and liver function within CTCAE grade 1 elevation; Voluntary participation, signed informed consent, good compliance, willing to cooperate with follow-up

Ki nem vehet részt

• Pregnant or lactating; Received anti-tumor drug therapy for cholangiocarcinoma before or after surgery; Cardiac, pulmonary, or renal insufficiency, severe hepatic insufficiency (Child-Pugh C): (1) severe cardiovascular diseases; (2) severe respiratory diseases; (3) renal disease: chronic renal failure, MDRD ≥ stage III; (4) uncontrolled active infection; (5) ASA > 3; (6) BMI ≥ 35; Active gastrointestinal bleeding, ulcer, refractory ascites; Uncorrectable hypertension, coagulopathy, or severe portal hypertension; Tumor recurrence within 1 month after surgery; History of other malignancies; Received other investigational drugs within 28 days; Deemed unsuitable by the investigator; Allergy \& Contraindications: severe allergy to iodine contrast media unmanageable by premedication, or contraindications to angiography; Postoperative pathology confirmed non-cholangiocarcinoma