Lenvatinib for Unresectable Intrahepatic Cholangiocarcinoma
Lenvatinib for Unresectable Intrahepatic Cholangiocarcinoma
The purpose of this study is to evaluate the efficacy and safety of lenvatinib for patients
 with unresectable intrahepatic cholangiocarcinoma
Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced
 hepatocellular carcinoma.No study has evaluated the efficacy and safety of lenvatinib in
 unresectable intrahepatic cholangiocarcinoma. Thus, the investigators carried out this
 prospective study to find out it.
Inclusion Criteria:

 -  The diagnosis of unresectable ICC

 -  Patients must have at least one tumor lesion that can be accurately measured according
 to mRECIST criteria.

 -  With no previous treatment

 -  No Cirrhosis or cirrhotic status of Child-Pugh class A only

 -  Not amendable to surgical resection ,local ablative therapy and any other cured
 treatment.

 -  The following laboratory parameters:

 Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/ L Serum albumin
 ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of
 normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3

 Exclusion Criteria:

 -  Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or
 hepatic encephalopathy

 -  Known history of HIV

 -  History of organ allograft

 -  Known or suspected allergy to the investigational agents or any agent given in
 association with this trial.

 -  Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

 -  Evidence of bleeding diathesis.

 -  Patients with clinically significant gastrointestinal bleeding within 30 days prior to
 study entry.

 -  Known central nervous system tumors including metastatic brain disease