Treatment Patients With Pulmonary Metastasis of Liver Cancer With Apatinib Combination With TACE: a Clinical Study
1 other identifier
interventional
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hepatocellular-carcinoma
Started Mar 2016
Typical duration for phase_2 hepatocellular-carcinoma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedFirst Posted
Study publicly available on registry
March 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedMarch 8, 2016
March 1, 2016
2 years
February 21, 2016
March 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (4)
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.
Objective response rate
1 month post intervention
The Quality of Life
0 to 24 months post intervention
Toxicity as measured by CTCAE V4.0
0 to 24 months post intervention
Study Arms (2)
Apatinib & TACE
EXPERIMENTALApatinib 500mg tablet by mouth per day, until disease progression, combined with TACE therapy one times every 4-6 weeks.
TACE
ACTIVE COMPARATORTACE therapy one times every 4-6 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- clinical diagnosis of hepatocellular carcinoma
- refused to sorafenib treatment
- have at least one measurable pulmonary lesions
- expected survival time ≥ 12 weeks
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhejiang Cancer Hospitallead
- First Affiliated Hospital of Zhejiang Universitycollaborator
- Second Affiliated Hospital, School of Medicine, Zhejiang Universitycollaborator
- The Central Hospital of Lishui Citycollaborator
- First Affiliated Hospital of Wenzhou Medical Universitycollaborator
- Ningbo No.2 Hospitalcollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
guoliang shao, phD
Zhejiang Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice President
Study Record Dates
First Submitted
February 21, 2016
First Posted
March 8, 2016
Study Start
March 1, 2016
Primary Completion
March 1, 2018
Study Completion
March 1, 2019
Last Updated
March 8, 2016
Record last verified: 2016-03