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

Phase 2

• Conditions: Pulmonary Metastasis; Hepatocellular Carcinoma
• Interventions: Drug: Apatinib; Procedure: TACE

• Registration Number: NCT02702323
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-02-21
• Status Verified: 2016-03
• Study Start: 2016-03
• Study First Submitted QC: 2016-03-02
• Last Update Submitted: 2016-03-02
• Study First Posted: 2016-03-08
• Last Update Posted: 2016-03-08
• Primary Completion: 2018-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Progress Free Survival	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

Secondary Outcome Measures

Name	Time	Method
overall survival	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.
Objective response rate	1 month post intervention	Time to progress of lung lesions which was confirmed by CT/MRI
The Quality of Life	0 to 24 months post intervention
Toxicity as measured by CTCAE V4.0	0 to 24 months post intervention