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

NCT ID: NCT02702323

Last Updated: 2016-03-08

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

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2019-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma Pulmonary Metastasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Apatinib & TACE

Apatinib 500mg tablet by mouth per day, until disease progression, combined with TACE therapy one times every 4-6 weeks.

Group Type EXPERIMENTAL

Apatinib

Intervention Type DRUG

apatinib 500mg/day for 6 weeks began taking 4-7 days after TACE

TACE

Intervention Type PROCEDURE

one times every 4-6 weeks.

TACE

TACE therapy one times every 4-6 weeks.

Group Type ACTIVE_COMPARATOR

TACE

Intervention Type PROCEDURE

one times every 4-6 weeks.

Interventions

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Apatinib

apatinib 500mg/day for 6 weeks began taking 4-7 days after TACE

Intervention Type DRUG

TACE

one times every 4-6 weeks.

Intervention Type PROCEDURE

Other Intervention Names

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transcatheter arterial chemoembolization

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role collaborator

The Central Hospital of Lishui City

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

Ningbo No.2 Hospital

OTHER

Sponsor Role collaborator

Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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guoliang shao

Vice President

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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guoliang shao, phD

Role: STUDY_CHAIR

Zhejiang Cancer Hospital

Central Contacts

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guoliang shao, phD

Role: CONTACT

+86 13958183472

liwen guo, MD

Role: CONTACT

+86 18329130398

Other Identifiers

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Ahead-H302

Identifier Type: -

Identifier Source: org_study_id

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