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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02702323
• Other study ID #: Ahead-H302
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: February 21, 2016
• Last updated: March 2, 2016
• Start date: March 2016
• Est. completion date: March 2019

Study information

• Verified date: March 2016
• Source: Zhejiang Cancer Hospital
• Contact: guoliang shao, phD
• Phone: +86 13958183472
• Email: shaoguoliang2008[@]126.com
• Is FDA regulated: No
• Health authority: china: zhejiang cancer hospital
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 2019
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Lung Neoplasms
• Neoplasm Metastasis
• Pulmonary Metastasis

Intervention

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

Procedure:
• TACE
one times every 4-6 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (6)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progress Free Survival	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.	No
Secondary	overall survival	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.	No
Secondary	Objective response rate	Time to progress of lung lesions which was confirmed by CT/MRI	1 month post intervention	No
Secondary	The Quality of Life		0 to 24 months post intervention	Yes
Secondary	Toxicity as measured by CTCAE V4.0		0 to 24 months post intervention	Yes