Lenvatinib for Unresectable Intrahepatic Cholangiocarcinoma

Sponsor

Sun Yat-sen University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03801499

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Intrahepatic Cholangiocarcinoma	Drug: Lenvatinib	Phase 2

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 cholangiocarcinoma. Thus, the investigators carried out this prospective study to find out it.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Lenvatinib for Unresectable Intrahepatic Cholangiocarcinoma: a Single-arm, Phase 2 Trial

Actual Study Start Date :

Sep 1, 2018

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing.

Arm

Intervention/Treatment

Experimental: 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.

Drug: Lenvatinib

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

Outcome Measures

Primary Outcome Measures

overall survival (OS) [12 months]
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.

Secondary Outcome Measures

progression free survival (PFS) [12 months]
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.
Objective Response Rate (ORR) [12 months]
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.
Adverse Events [12 months]
Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.03

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Center Sun Yat-sen University	Guangzhou	Guangdong	China	510060

Sponsors and Collaborators

Sun Yat-sen University

Investigators

Principal Investigator: Ming Shi, MD, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shi Ming, Clinical Professor, Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT03801499

Other Study ID Numbers:

HCC-S073

First Posted:

Jan 11, 2019

Last Update Posted:

May 21, 2020

Last Verified:

May 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Shi Ming, Clinical Professor, Sun Yat-sen University

Intrahepatic Cholangiocarcinoma

Lenvatinib

Additional relevant MeSH terms:

Cholangiocarcinoma

Lenvatinib

Study Results

No Results Posted as of May 21, 2020