Biliary Tract Tumor
Conditions
Interventions
Adebrelimab:Adabelimab: 1200mg, iv,d1,Q3W
Epimedium soft capsules: 6 capsules/time (0.4g/capsule), po,bid, Swallow in warm water 30 minutes after breakfast and dinner
Chemotherapy regimen: Cisplatin 25mg/m2, Iv d1 and d8, Q3W
Gemcitabine 1000mg/m2, Iv d1 and d8, Q3W.
The specific drug dosage is determined by the researcher based on the actual situation of the patient, and should not exceed 8 chemotherapy cycles.
Carilizumab:Carilizumab: 200 mg, iv, d1, Q3W
Sponsors
Lanzhou University Second Hospital (Second Clinical School)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign an informed consent form to participate in this study; 2. Age>=18 years old, gender not limited; 3. Histologically confirmed, unresectable, locally advanced or metastatic BTC patients, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder cancer; 4. BTC patients diagnosed with unresectable or metastatic BTC for the first time and who have not received previous treatment; At baseline, there must be at least one target lesion (TL) that meets the RECIST 1.1 criteria; 6. Expected survival period>6 months; 7. ECOG score: 0 to 1; 8. Have not received immune checkpoint inhibitor treatment in the past; 9. Organs and bone marrow have sufficient function, defined as follows: 1) Blood routine: hemoglobin >=90g/L without transfusion; Absolute neutrophil count = 1.5 × 109/L; Platelet count >=80 × 109/L. 2) Liver function: serum albumin >= 28 g/L; Aspartic acid or alanine aminotransferase<=2.5 ULN, for patients with liver metastases, ALT and AST should be<= 5 × ULN; Total bilirubin<3 × ULN, Any clinically significant biliary obstruction must be resolved before enrollment in the study. 3) Renal function: Serum creatinine <=1.5 × ULN. 10. Female subjects with reproductive potential or male subjects with reproductive potential partners shall adopt efficient contraceptive measures throughout the study period; 11.Expected to have good compliance and be able to cooperate with the research according to the requirements of the plan.
Exclusion criteria
Exclusion criteria: 1. Individuals who are known to be allergic to the ingredients in the investigational drug or have metabolic disorders; 2. Simultaneously participating in other tumor trial drugs or currently undergoing clinical trials for other tumors. 3. Serious liver disease (such as cirrhosis), kidney disease, respiratory disease or chronic system diseases such as uncontrollable diabetes and hypertension; 4. Heart diseases with obvious clinical symptoms, such as congestive heart failure, coronary heart disease with obvious symptoms, arrhythmia that is difficult to control with medication, NYHA grade 2 or above heart failure, and left ventricular ejection fraction (LVEF)10000 IU/ml and abnormal liver function; Untreated hepatitis C or co infection of hepatitis B and hepatitis C; 10. Pregnant and lactating women who have reproductive abilities are unwilling to take effective contraceptive measures; 11.Other researchers believe that patients who are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;PFS;OS;Safety; | — |
Countries
China
Contacts
Public ContactZhou Wence
Lanzhou University Second Hospital (Second Clinical School)
Outcome results
None listed