Lenvatinib for Unresectable Intrahepatic Cholangiocarcinoma

Sun Yat-sen University

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Intrahepatic Cholangiocarcinoma

Interventions

LenvatinibDRUG

12 mg (or 8 mg) once daily (QD) oral dosing.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

overall survival (OS)

OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.

Time frame: 12 months

Secondary Outcomes

progression free survival (PFS)

PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first.

Time frame: 12 months

Objective Response Rate (ORR)

ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on mRECIST. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference to the baseline sum of the diameters of target lesions.

Time frame: 12 months

Adverse Events

Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.03

Time frame: 12 months

Data from ClinicalTrials.gov

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