Clinical trial NCT02702323: Treatment Patients With Pulmonary Metastasis of Liver Cancer With Apatinib Combination With TACE: a Clinical Study
Official title: Treatment Patients With Pulmonary Metastasis of Liver Cancer With Apatinib Combination With TACE: a Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Hepatocellular Carcinoma
Pulmonary Metastasis
Keywords: hepatocellular carcinoma
pulmonary metastasis
Apatinib
efficacy
safety
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Zhejiang University
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: The Central Hospital of Lishui City
name: First Affiliated Hospital of Wenzhou Medical University
name: Ningbo No.2 Hospital
First posted: 2016-03-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Progress Free Survival
timeFrame: 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 outcomes:
measure: overall survival
timeFrame: 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.
measure: Objective response rate
timeFrame: 1 month post intervention
measure: The Quality of Life
timeFrame: 0 to 24 months post intervention
measure: Toxicity as measured by CTCAE V4.0
timeFrame: 0 to 24 months post intervention
Other outcomes:
Locations:
Study officials:
affiliation: Zhejiang Cancer Hospital
name: guoliang shao, phD
role: STUDY_CHAIR
References: