Status:
WITHDRAWN
Lenvatinib for Unresectable Intrahepatic Cholangiocarcinoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Intrahepatic Cholangiocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of lenvatinib for patients with unresectable intrahepatic cholangiocarcinoma
Detailed Description
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 ch...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03801499
Start Date
September 1 2018
End Date
December 1 2019
Last Update
May 21 2020
Active Locations (1)
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1
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China, 510060