Advanced or Metastatic Cholangiocarcinoma
Cholangiocarcinoma
About this trial
This is an interventional treatment trial for Cholangiocarcinoma
Eligibility Criteria
Inclusion Criteria: Patients with advanced, pathologically unresectable or metastatic bile duct epithelial cell carcinoma; Previously received a chemotherapy regimen (including gemcitabine) anti-tumor systemic therapy, but did not use albumin binding paclitaxel; Age ≥18 years old and under 75 years old; Predicted survival ≥3 months; ECOG score 0-1; Child-Pugh score<8 There was at least one measurable tumor lesion with a long diameter ≥10 mm and a short diameter ≥15 mm on spiral CT. For general CT or physical examination, the maximum diameter must be ≥20mm; The results of liver and kidney function and blood routine examination within 1 week before enrollment were consistent with the following conditions, ANC≥1.5×10^9/L,PLT≥80×10^9/L,HGB≥80g/L,Cr≤1.5×ULN,TBIL≤2.5×ULN,ALP≤2.5×ULN,AST≤2.5×ULN,ALT≤2.5×ULN Patients participate voluntarily and sign informed consent forms Exclusion Criteria: Known to be severely allergic to carrilizumab, apatinib, and albumin paclitaxel; Obstructive jaundice cannot be achieved 2.5×ULN after surgical intervention; Patients with biliary obstruction that may occur or worsen within 4 to 6 weeks; Patients with obvious coagulation mechanism disorder, active bleeding and bleeding tendency; History of other malignancies within 5 years (fully treated basal cell carcinoma of the skin, out-of-situ cervix); Interstitial pneumonia or pulmonary fibrosis; Uncontrollable pleural effusion or ascites; Severe uncontrolled medical disease, acute infection, recent history of myocardial infarction (within 3 months); Pregnant or lactating mothers who refused to use appropriate contraceptive methods during the course of this study; The researchers determined that the patients were not suitable for this study.
Sites / Locations
Arms of the Study
Arm 1
Experimental
Advanced or metastatic cholangiocarcinoma
A multicenter clinical study of carralizumab combined with albumin paclitaxel and apatinib mesylate in the second-line treatment of advanced or metastatic cholangiocarcinoma.Albumin-bound paclitaxel 125 mg/m2 d1,8; Carrilizumab 200mg Q3W d1; Apatinib mesylate tablet treatment: 250mg orally, once a day, continuous administration. Treatment continued or was evaluated every 2 cycles until disease progression or toxic side effects of patient intolerance to the treatment regimen.