Lenvatinib for Unresectable Intrahepatic Cholangiocarcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-12-31

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of lenvatinib for patients with unresectable intrahepatic cholangiocarcinoma

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Detailed Description

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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.

Conditions

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Intrahepatic Cholangiocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lenvatinib

Participants received lenvatinib capsules 12 milligram (mg) based on the participant's body weight greater than or equal to (\>=) 60 kilogram (kg) or 8 mg based on the participant's body weight less than (\<) 60 kg at baseline, orally, once daily (QD) up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

Group Type EXPERIMENTAL

Lenvatinib

Intervention Type DRUG

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

Interventions

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Lenvatinib

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No