Treatment Patients With Pulmonary Metastasis of Liver Cancer With Apatinib Combination With TACE: a Clinical Study

March 2, 2016 updated by: guoliang shao, Zhejiang Cancer Hospital
This study mainly evaluate the clinical effect of Apatinib in the treatment of patients with pulmonary metastasis of hepatocellular carcinoma.Half of participants will receive Apatinib and transcatheter arterial chemoembolization (TACE) therapy in combination,while the other half will receive TACE therapy alone.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Apatinib is a VEGFR targeting tyrosine kinase inhibitor, which has preliminary demonstrated the efficacy and safety in treatment of advanced hepatocellular carcinoma by phase II stage research. Pulmonary metastasis of hepatocellular cancer is one of the difficulties in clinical practice,because it's not sensitive to systemic chemotherapy.This phase Ⅲ study aims to evaluates the efficacy and safety of the Apatinib in the treatment of advanced hepatocellular cancer with pulmonary metastasis.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • 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.

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • clinical diagnosis of hepatocellular carcinoma
  • refused to sorafenib treatment
  • have at least one measurable pulmonary lesions
  • expected survival time ≥ 12 weeks

Exclusion Criteria:

  • within four weeks before the study received radiotherapy or chemotherapy
  • With a variety of factors influencing oral drugs taking and absorption (such as unable to swallow, chronic diarrhea and intestinal obstruction)

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Apatinib & TACE
Apatinib 500mg tablet by mouth per day, until disease progression, combined with TACE therapy one times every 4-6 weeks.
Drug: Apatinib
apatinib 500mg/day for 6 weeks began taking 4-7 days after TACE
Procedure: TACE
one times every 4-6 weeks.
Other Names:
  • transcatheter arterial chemoembolization
Active Comparator: TACE
TACE therapy one times every 4-6 weeks.
Procedure: TACE
one times every 4-6 weeks.
Other Names:
  • transcatheter arterial chemoembolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progress Free Survival
Time Frame: Change from Baseline mRECIST at 12 months was assessed every 4 weeks up to 48 weeks. Data collection is from date of randomization until the date of first documented progression assessed up to 12 months.
PFS is defined as the months that from the anticipation of the clinical-trial to the progress of hepatocellular cancer
Change from Baseline mRECIST at 12 months was assessed every 4 weeks up to 48 weeks. Data collection is from date of randomization until the date of first documented progression assessed up to 12 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: Survival assessed every 4 weeks up to 24 months following objective disease progression. Data collection is from date of randomization until the date of death from any cause, assessed up to 48 months.
OS is defined as the months that from the anticipation of the clinical-trial to the death of patients.
Survival assessed every 4 weeks up to 24 months following objective disease progression. Data collection is from date of randomization until the date of death from any cause, assessed up to 48 months.
Objective response rate
Time Frame: 1 month post intervention
Time to progress of lung lesions which was confirmed by CT/MRI
1 month post intervention
The Quality of Life
Time Frame: 0 to 24 months post intervention
0 to 24 months post intervention
Toxicity as measured by CTCAE V4.0
Time Frame: 0 to 24 months post intervention
0 to 24 months post intervention

Collaborators and Investigators

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

Sponsor

Zhejiang Cancer Hospital

Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University
First Affiliated Hospital of Zhejiang University
The Central Hospital of Lishui City
First Affiliated Hospital of Wenzhou Medical University
Ningbo No.2 Hospital

Investigators

  • Study Chair: guoliang shao, phD, Zhejiang Cancer Hospital

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

March 1, 2016

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

February 21, 2016

First Submitted That Met QC Criteria

March 2, 2016

First Posted (Estimate)

March 8, 2016

Study Record Updates

Last Update Posted (Estimate)

March 8, 2016

Last Update Submitted That Met QC Criteria

March 2, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ahead-H302

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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