Extrahepatic cholangiocarcinoma
Conditions
Interventions
Adjuvant treatment group:Tislelizumab plus capecitabine
Sponsors
Cancer Hospital Affiliated to Chongqing University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) 18-75 years old, male or female; 2) ECOG PS score 0-1; 3) Diagnosed with extrahepatic cholangiocarcinoma (including hilar cholangiocarcinoma and distal cholangiocarcinoma) and underwent radical resection; 4) Meet at least one of the following risk factors for recurrence (CA19-9 level > 200 U/ml; Microvascular invasion; Lymph node metastasis; Peripheral nerve invasion); 5) No other local or systemic treatment was performed after surgery; 6) No other systemic malignancies; 7) Normal organ function, and meet the following conditions: neutrophil =1500/µL; Platelet =60,000/µL; Hemoglobin > 8.5 g/dL; Plasma albumin > 3.0 g/dL; Total bilirubin < 30mmol/L; ALT and AST were lower than 5 times the upper limit of normal. INR < 1.7 or PT extension not exceeding 4 seconds; Blood creatinine is less than 1.5 times the upper limit of normal; 8) The patient knows his condition and signs a written informed consent.
Exclusion criteria
Exclusion criteria: 1) Previously received any antitumor therapy for cholangiocarcinoma; 2) History of heart disease or uncontrolled hypertension (>150/100mmHg); 3) History of thrombotic disease or gastrointestinal bleeding within 6 months; 4) History of other malignant tumors; 5) Patients who have participated in other clinical trials within 4 weeks; 6) Allergic to tislelizumab; 7) Patients with active infection; 8) Patients with HIV infection; 9) An active autoimmune disease requiring systemic treatment (e.g. with disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years prior to initial administration. Replacement therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy; 10) Patients with acute or chronic active hepatitis B or hepatitis C, HBV DNA=200000IU/ml or 10^6 copies /ml; Hepatitis C virus HCV RNA=10^3 copies /ml; Hepatitis B surface antigen (HbsAg) and anti-HCV antibodies were both positive. 11) Pregnant or lactating women; 12) Other factors that may affect patient enrollment and evaluation results; 13) The investigators assessed patients with poor compliance and could not guarantee treatment and follow-up according to the study protocol. 14) Patients deemed unsuitable for inclusion by other investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year RFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| mRFS;1-year RFS rate;3-year RFS rate;1-year OS rate;2-year OS rate;3-year OS rate;Safety; | — |
Countries
China
Contacts
Public ContactDewei Li
Cancer Hospital Affiliated to Chongqing University
Outcome results
None listed