Malignant tumor of biliary system
Conditions
Interventions
Sponsors
Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18 or above, regardless of gender; Gallbladder carcinoma and extrahepatic cholangiocarcinoma diagnosed by histology or cytology after radical operation; 2. R0 / R1 resected patients with T2-4 or N1 pathological stage after operation; No more than 12 weeks after radical operation; 3. Subjects with ECoG score of 0-1; 4. Subjects whose expected survival time is more than 6 months; 5. There was no infection in the subjects with good biliary drainage; 6. Subjects who have not received radiotherapy, chemotherapy or immunotherapy for primary tumor; 7. Adequate organ function Blood routine examination: no blood transfusion, no use of G-CSF, no use of drugs within 14 days before screening (object correction) ANC >= 1.5 x 10^9/L Hb >= 100g/L PLT >= 100 x 10^9/L 8. Biochemical examination (no ALB transfusion within 14 days before screening) ALB >= 35g/L ALT = 50ml / min (standard Crockcroft Gault formula) 9. The subjects who volunteered to join the study signed the informed consent with good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with local recurrence or distant metastasis (including ascites or malignant pleural effusion); 2. Patients with severe cardiovascular diseases, such as heart failure of grade 2 or above, unstable angina pectoris, unstable arrhythmia or color photos of heart, showed LVEF 10mg / day or equivalent); 6. Patients with other active malignant tumors within 5 years before the first use of the study drug. Cured localized tumors, such as basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder cancer, and prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ can be included in the group; 7. Patients with active viral hepatitis (e.g. hepatitis B, hepatitis C, unless receiving antiviral therapy and HBV or HCV viral load is lower than the minimum detection limit, they can be considered), HIV positive or have a history of acquired immunodeficiency syndrome; 8. Patients within 14 days before the first medication had any activity requiring systemic anti infective treatment Dyeing; 9. Patients with active tuberculosis in the past year, whether or not treated; 10. Subjects who had used live attenuated vaccine within 28 days before screening; 11. Subjects who have received allogeneic bone marrow transplantation or solid organ transplantation in the past; 12. Subjects who received any other trial drug treatment within 28 days before signing the ICF; 13. Subjects with dysphagia or known malabsorption of drugs; 14. Pregnant or lactating women; 15. Subjects of childbearing age who refused to use effective contraceptives; 16. Other conditions considered unsuitable by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactLiwei Wang
Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University
Outcome results
None listed