Biliary tract cancers
Conditions
Interventions
Adebelimab combined with capecitabine group:1. Adelbelimab: 20mg/kg, once every 3 weeks, for 1 course of treatment. A total of 8 courses of treatment.
2. Capecitabine: 2500mg/m2, divided into 2 times
Sponsors
Sir Run-Run Shaw Hospital, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years old; 2. Patients who were diagnosed as BTCs at our hospital; 3. Preoperative imaging examination showed BTCs with hilar lymphadenopathy; 4. Receive radical surgery for BTCs with positive lymph nodes and negative resection margin; 5. Receive adjuvant treatment after surgery; 6. Immunophenotyping is immune non-superprogressive; 7. The functional indicators of important organs meet the following requirements: neutrophil >= 1.5 x 10^9/L; Platelet >= 90 x 10^9/L; Hemoglobin >= 9g/dL; serum albumin >= 3.5 g/dL; Coagulation function: international standardized (prothrombin time) ratio (INR) = 60 mL/min; 8. Voluntarily participate in this study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received systematic therapy with PD1 antibody, PDL1 antibody or CTLA4 antibody, TKI inhibitor and chemotherapy; Participated in other clinical trials 30 days prior to screening; 2. Previous or concurrent malignant tumors; 3. Known hepatitis B virus (HBV) carriers must exclude active HBV infection, that is, HBV DNA positive (> 1 x 10^4 copies/mL or > 2000 IU/mL); Known hepatitis C virus (HCV) and HBV DNA positive (> 1 x 10^3 copies/mL), other hepatitis, cirrhosis; 4. Active tuberculosis infection. Patients with active tuberculosis infection within 1 year prior to treatment; Have a history of active tuberculosis infection more than 1 year before treatment, have not received regular anti-tuberculosis therapy, or have active tuberculosis; 5. Have active, known or suspected autoimmune diseases. Participants with hypothyroidism requiring hormone replacement therapy and skin diseases requiring systemic therapy were eligible; 6. Previous interstitial lung disease, or (non-infectious) pneumonia requiring oral or intravenous steroid hormone therapy; 7. Long-term reception of systemic hormones (dose equivalent to > 10 mg of prednisone / day) or any other form of immunosuppressive therapy; Participants on inhaled or topical corticosteroids could be enrolled; 8. Active infections requiring systemic treatment; 9. Positive for human immunodeficiency virus (HIV, HIV 1/2 antibodies); 10. Clinically significant bleeding symptoms or a clear tendency to appear within 3 months before treatment; 11. Vulnerable groups, including the mentally ill, cognitively impaired, critically ill, minors, pregnant women, illiterate, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival;Recurrence-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events;Severe adverse events;Quality of life; | — |
Countries
China
Contacts
Public ContactChen Mingyu
Sir Run-Run Shaw Hospital, Zhejiang University
Outcome results
None listed