Biliary Tract Carcinoma
Conditions
Interventions
Experimental:Participants will receive gemcitabine plus cisplatin for 6-8 cycles, and tislelizumab until disease progression, unacceptable toxicity or death
Sponsors
Tangshan central hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Provide written Informed consent. 2. Age = 18 years old = 75 years old, regardless of gender. 3. Diagnosed as unresectable biliary tract carcinoma by histopathology or cytology, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma. 4. Has received no prior systemic therapy for BTC. 5. Has Child-Pugh A classification for liver function. 6. The expected survival = 3 months. 7. Has at least one measurable lesion per RECIST 1.1. 8. Has ECOG PS score 0-1. 9. Has adequate organ function. 10. If a female of childbearing potential (ie, physiologically capable of becoming pregnant), agree to have a negative urine or serum pregnancy test within 3 days of the first study drug administration. 11. If a female of childbearing potential or non-sterile male, agrees to practice highly effective methods of birth control for the duration of the study and for >120 days after the last dose of tislelizumab.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of other malignant diseases outside BTC within 5 years prior to first dosing. 2. Received other investigational drugs or used investigational devices within 4 weeks prior to first dosing. 3. Previous therapy: anti-PD-1, anti-PD-L1, or drugs that target another stimulus or synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137). 4. Received proprietary Chinese medicines with anti-tumor indications or immunomodulatory effects within 2 weeks prior to first dosing. 5. An active autoimmune disease requiring systemic treatment has occurred within 2 years prior to first dosing. 6. Received systemic glucocorticoid therapy within 4 weeks prior to first dosing. 7. Obstructive jaundice 8. Known allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 9. Known to be allergic to the active ingredient or excipient of the drug in this study. 10. Has not fully recovered from the toxicity and/or complications caused by any intervention before starting treatment. 11. Known history of human immunodeficiency virus (HIV) infection. 12. Untreated active HBV or HCV. 13. Received live attenuated vaccine within 4 weeks prior to first dosing. 14. Pregnant or lactating women. 15. Presence of any serious or uncontrolled systemic disease. 16. Evidence of medical history or disease that may interfere with the test results, prevent participants from participating fully in the study, abnormal treatment or laboratory test values, or other conditions that the investigator deems unsuitable for enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Disease control rate;Duration of response;1-year overall survival rate;Adverse event; | — |
Countries
China
Contacts
Public ContactZheng Jianxing
Tangshan central hospital
Outcome results
None listed