Carlizumab Plus Sovantinib in Second-line Treatment of Advanced or Metastatic Cholangiocarcinoma
Cholangiocarcinoma
About this trial
This is an interventional treatment trial for Cholangiocarcinoma
Eligibility Criteria
Inclusion Criteria: Advanced inability to root was pathologically confirmed Patients with curatively resected or metastatic bile duct epithelial cell carcinoma; had previously received systemic antitumor therapy with a chemotherapy regimen (including gemcitabine) Age ≥18 and under 75 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 allergies to carrilizumab or solfantinib machine components Patients with obstructive jaundice who could not reach the upper limit of TBIL≤2.5 times of normal value 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, cervical cancer in situ) 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 take appropriate contraceptive measures during the course of the 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
In this study, carrilizumab combined with sovantinib in the second-line treatment of patients with advanced or metastatic cholangiocarcinoma with single arm, open, Exploratory clinical trials.The specific treatment regimen was carrilizumab 200mg Q3W d1; Sofantinib: 300mg,Take orally, once a day, continuously. Treatment continues or until disease progression occurs or the patient becomes intolerant to treatment regimens.The efficacy was evaluated every 2 cycles.