Hepatocellular CarcinomaPhase 2/3NCT02702323
Treatment Patients With Pulmonary Metastasis of Liver Cancer With Apatinib Combination With TACE: a Clinical Study
A Phase 2/3 study testing Apatinib and TACE in people with Hepatocellular Carcinoma and Pulmonary Metastasis, run by Zhejiang Cancer Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Pulmonary Metastasis
- What is being tested?
- Apatinib and TACE
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Mar 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of hepatocellular carcinoma
- refused to sorafenib treatment
- have at least one measurable pulmonary lesions
- expected survival time ≥ 12 weeks
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma, Pulmonary Metastasis
- Keywords
- hepatocellular carcinoma, pulmonary metastasis, Apatinib, efficacy, safety
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
apatinib 500mg/day for 6 weeks began taking 4-7 days after TACE
TACEProcedure or surgery
Also called transcatheter arterial chemoembolization
one times every 4-6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Apatinib & TACE | Experimental | Apatinib 500mg tablet by mouth per day, until disease progression, combined with TACE therapy one times every 4-6 weeks. Receives: Drug: Apatinib; Procedure: TACE |
| TACE | Active comparator | TACE therapy one times every 4-6 weeks. Receives: Procedure: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress Free Survival
PFS is defined as the months that from the anticipation of the clinical-trial to the progress of hepatocellular cancer
Measured: 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
OS is defined as the months that from the anticipation of the clinical-trial to the death of patients.
Measured: 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
Time to progress of lung lesions which was confirmed by CT/MRI
Measured: 1 month post intervention
The Quality of Life
Measured: 0 to 24 months post intervention
Toxicity as measured by CTCAE V4.0
Measured: 0 to 24 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2018 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, Second Affiliated Hospital, Zhejiang University, School of Medicine, The Central Hospital of Lishui City, First Affiliated Hospital of Wenzhou Medical University, Ningbo No.2 Hospital
- Responsible party
- Principal investigator, guoliang shao, Zhejiang Cancer Hospital
- Investigators
- guoliang shao, phD, Study chair, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702323
- Sponsor's protocol ID
- Ahead-H302
- Status last verified
- Mar 2016
- First submitted
- 21 Feb 2016
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Patients With Pulmonary Metastasis of Liver Cancer With Apatinib Combination With TACE: a Clinical Study
- ClinicalTrials.gov ID
- NCT02702323
- Acronym / sponsor ID
- Ahead-H302
- Conditions
- Hepatocellular Carcinoma, Pulmonary Metastasis
- Keywords
- hepatocellular carcinoma, pulmonary metastasis, Apatinib, efficacy, safety
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, Second Affiliated Hospital, Zhejiang University, School of Medicine, The Central Hospital of Lishui City, First Affiliated Hospital of Wenzhou Medical University, Ningbo No.2 Hospital
- Study start
- Mar 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apatinib & TACE | Experimental | Drug: Apatinib, Procedure: TACEApatinib 500mg tablet by mouth per day, until disease progression, combined with TACE therapy one times every 4-6 weeks. |
| TACE | Active comparator | Procedure: TACETACE therapy one times every 4-6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- clinical diagnosis of hepatocellular carcinoma
- refused to sorafenib treatment
- have at least one measurable pulmonary lesions
- expected survival time ≥ 12 weeks
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apatinibapatinib 500mg/day for 6 weeks began taking 4-7 days after TACE | Drug | Apatinib & TACE |
| TACEAlso: transcatheter arterial chemoembolizationone times every 4-6 weeks. | Procedure or surgery | Apatinib & TACE, TACE |
Primary outcome
Progress Free Survival
Time frame: 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
4 secondary outcomes
overall survival
Time frame: 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
Time frame: 1 month post intervention
The Quality of Life
Time frame: 0 to 24 months post intervention
Toxicity as measured by CTCAE V4.0
Time frame: 0 to 24 months post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
guoliang shao, phD study chair
Zhejiang Cancer Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Apatinib and TACE in people with Hepatocellular Carcinoma and Pulmonary Metastasis, run by Zhejiang Cancer Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact guoliang shao, phD (+86 13958183472, shaoguoliang2008@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress Free Survival (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016.