Biliary Tract Carcinoma
Conditions
Interventions
Experimental group:Cardunelimab 10 mg/kg, Q3W+ radiotherapy
Sponsors
Eastern Hepatobiliary Surgery Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Between 18 and 75 years old, regardless of gender; 2) Histology or cytology confirmed to be a malignant tumor of the biliary tract (intrahepatic bile duct cancer, extrahepatic bile duct cancer and gallbladder cancer); 3) Advanced patients who have failed or relapsed after receiving first-line treatment, intrahepatic and lymph node metastasis, or patients who are unable to undergo chemotherapy; 4) There is at least one measurable lesion according to the RECIST1.1 standard; 5) Liver function Child level A or B can be improved to level A through active medical treatment. Kidney function and cardiopulmonary function are basically normal. Hemoglobin =90g/L, white blood cell count =3.0×109/L, neutrophil count =1.5×109/L, platelet count =75×109/L; 6) ECOG PS score is 0-1; the expected life expectancy is more than 3 months, there is no HCV, HIV or syphilis infection, can understand the situation of this study and has signed an informed consent form; 7) All acute toxic reactions caused by previous anti-tumor treatment are relieved to level 0-1 (according to NCI CTCAE version 5.0) or to an acceptable level of selection/exclusion criteria; 8) Total triiodothyrogenine (T3) or free T3 and free thyroxine (T4) are within the normal range (can be controlled by thyroid replacement therapy). Asymptomatic T3, free T3 or free T4 abnormal subjects can be selected; 9) Fully control blood pressure.
Exclusion criteria
Exclusion criteria: 1) Pleural fluid, ascites and pericardial effusion with clinical symptoms that need to be drained; 2) Liver function CHILD B level cannot be corrected, CHILD C level; 3) Those who are unable to tolerate or cooperate with radiotherapy; 4) Those who have severe varicature of the esophageal and gastric vein or have a previous history of hemorrhage in the digestive tract; 5) Have a history of hepatic encephalopathy or a history of liver transplantation; 6) Central nervous system metastasis; 7) Female patients who are pregnant or breastfeeding; 8) The residual lesions after the previous radiotherapy coincided with the location of this radiotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate;progression free survival;overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;safety; | — |
Countries
China
Contacts
Public ContactMeng Yan ,Xie Feng
Eastern Hepatobiliary Surgery Hospital
Outcome results
None listed