Cholangiocarcinoma
Conditions
Interventions
Experimental group:DEB-TACE+apatinib+camrelizumab
Sponsors
Fujian Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80, male or female; 2. Patients with intrahepatic cholangiocarcinoma confirmed by pathological examination, and at least one measurable lesion(RECIST v1.1); 3. Patients with locally advanced or metastatic ICC who have not received systematic treatment and cannot be cured(AJCC v8); 4. Chlid-Pugh=3 months; 7. The main organs function normally and meet the following criteria: (1) Blood routine examination standards shall meet the following standards: (no blood transfusion within 14 days) 1) Hemoglobin (HB)>=90g/L; 2) White blood cell count (WBC)>=3*10^9/L; 3) Absolute neutrophil count (ANC)>=1.5*10^9/L; 4) Platelet (PLT)>=50*10^9/L; (2) Biochemical examination shall meet the following standards: 1) Bilirubin (bil)<1.5 times the upper limit of normal value (ULN); 2) Alanine aminotransferase (ALT) and aspartate aminotransferase(AST)< 5ULN; 3) Serum creatinine (Cr)<=1.5ULN; 8. Women of childbearing age must have a negative pregnancy test (serum) or urinary HCG test within 7 days before enrollment, and are willing to use appropriate methods of contraception during treatment; For men, surgical sterilization should have been performed or appropriate contraceptive methods should be used during treatment; 9. The patents voluntarily joined the study, had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Patients with autoimmune diseases, organ / hematopoietic stem cell transplantation or other malignant tumors (except cured basal cell carcinoma and cervical carcinoma in situ); 3. Previous treatment with apatinib, carrelizumab, or other PD-1/PD-L1 inhibitors; 4. Severe liver, kidney, heart, lung, brain, and other major organ failures; 5. Active infection, especially inflammation of biliary system; 6. Uncorrectable coagulation dysfunction and serious hemogram abnormalities, with the tendency of serious bleeding; 7. According to the judgment of the investigator, there are other accompanying diseases that seriously endanger the safety of the patient or affect the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Disease Control Rate;Objective Response Rate;Safety; | — |
Countries
China
Contacts
Public ContactYubin Hu
Fujian Provincial Cancer Hospital
Outcome results
None listed