Overview
Lenvatinib for Unresectable Intrahepatic Cholangiocarcinoma
Status:
Withdrawn
Withdrawn
Trial end date:
2019-12-01
2019-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to evaluate the efficacy and safety of lenvatinib for patients with unresectable intrahepatic cholangiocarcinomaPhase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Sun Yat-sen UniversityTreatments:
Lenvatinib
Criteria
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