The Efficacy of Transarterial Chemoinfusion (TAI) Combine Lenvatinib in Advanced Hepatocellular Carcinoma (HCC)

August 12, 2019 updated by: Rong-ping Guo, Sun Yat-sen University
evaluation of the efficacy of transarterial chemoinfusion (TAI) combine lenvatinib in advanced hepatocelllar carcinoma

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

206

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

older than 18 years old and younger than 75 years; ECOG PS≤1; proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria; not previous treated for tumor; unresectable; the lab test could meet: neutrophil count≥2.0×109/L; hemoglobin≥100g/L; platelet count≥75×109/L; serum albumin≥35g/L; total bilirubin<2-times upper limit of normal; ALT<3-times upper limit of normal; AST<3-times upper limit of normal; serum creatine<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2; sign up consent

Exclusion Criteria:

cannot tolerate TAI or surgery; known history of other malignancy; be allergic to related drugs; underwent organ transplantation before; be treated before (interferon included); known history of HIV infection; known history of drug or alcohol abuse; have GI hemorrhage or cardiac/brain vascular events within 30 days; pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TAI+lenvatinib group
TAI combine lenvatinib
Combination product: TAI combine lenvatinib
TAI combine lenvatinib
ACTIVE_COMPARATOR: lenvatinib group
lenvatinib only
Drug: Lenvatinib
lenvatinib only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: From date of randomization until the date of death from any cause, assessed up to 60 months
overall survival
From date of randomization until the date of death from any cause, assessed up to 60 months
PFS
Time Frame: From date of randomization until the date of progress from any cause, assessed up to 60 months
progression-free survival
From date of randomization until the date of progress from any cause, assessed up to 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: From date of randomization until the date of death from any cause, assessed up to 60 months
object response rate
From date of randomization until the date of death from any cause, assessed up to 60 months
DCR
Time Frame: From date of randomization until the date of death from any cause, assessed up to 60 months
disease control rate
From date of randomization until the date of death from any cause, assessed up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2018

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

August 10, 2019

First Submitted That Met QC Criteria

August 12, 2019

First Posted (ACTUAL)

August 13, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 13, 2019

Last Update Submitted That Met QC Criteria

August 12, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2019-076-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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