biliary tract cancer
Conditions
Interventions
Experimental group:Sintilimab plus gemcitabine and cisplatin
Sponsors
Eastern Hepatobiliary Surgery Hospital Second, Military Medical University, Shanghai, China
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sign ICF; 2. Aged 18 to 75 years old; 3. histopathological diagnosis: gallbladder cancer or cholangiocarcinoma; 4. ECOG PS 0-2; 5. R2 resection; 6. Liver function: Child-Pugh A; 7. Enough organ functions, subjects need to meet the following laboratory indicators: 1) The absolute value of neutrophils (ANC) >=1.0x10^9/L; 2) Platelets >=75x10^9/L; 3) Hemoglobin>9g/dL; 4) Total bilirubin=60 ml/min; 7) Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) <=1.5 ULN; 8) Normal thyroid function (thyroid stimulating hormone (TSH) within the normal range). If the baseline TSH is out of the normal range, FT3 and FT4 are normal can also be included in the group.
Exclusion criteria
Exclusion criteria: 1. Pathological diagnosis of non-biliary tumors during or after surgery, or R0/R1 resection; 2. History of other systemic tumors, except: 1) Adenocarcinoma in situ of the cervix; 2) Treated basal cell carcinoma; 3) Superficial bladder cancer (Ta, Tis and T1); 4) Any tumor that received radical treatment three years ago; 3. Have received immunotherapy previously; 4. Received anti-tumor systemic treatment within 2 weeks before the first administration; 5. Active autoimmune diseases; 6. Have received systemic glucocorticoid therapy within 7 days before the first administration of the study; 7. Uncontrollable pleural effusion/abdominal effusion (patients who do not need to drain the effusion or stop drainage for 3 days without a significant increase in effusion can be included); 8. Allergic to the active ingredients or excipients of Sintilimab, gemcitabine and cisplatin; 9. Before treatment, have not fully recovered from the toxicity and/or complications caused by any intervention (ie, = Grade 1 or reach baseline, excluding fatigue or hair loss); 10. Pregnant or lactating women; 11. Serious heart, brain, lung, kidney and blood system diseases; 12.Arterial and venous thrombosis within 6 months before enrollment, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism; 13. Participate in other clinical trials; 14. History of allogeneic organ transplantation; 15. Bleeding events at any location >=CTCAE grade 3, unhealed wounds, ulcers or fractures occurred 4 weeks before the medication; 16. Untreated intestinal obstruction that cannot eat or affects systemic administration; 17. HIV infection or AIDS-related diseases; 18. Inflammatory infections; 19. According to the judgment of the investigator, patients with concomitant diseases that may seriously endanger their safety or may affect the completion of the study 20. Those who have a history of mental illness or abnormal behavior, etc., and the investigator judges that they are not suitable for participating in clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| RFS;12m RFS rate;Safety; | — |
Countries
China
Contacts
Public ContactYong-jie Zhang
Eastern Hepatobiliary Surgery Hospital Second, Military Medical University
Outcome results
None listed