Liver CancerPhase 2/3NCT01932385
Sorafenib in Liver Function Impaired Advanced Hepatocellular Carcinoma
A Phase 2/3 study testing Sorafenib in people with Liver Cancer, run by Qingdao Central Hospital at 1 site in China.
Trial summary
Due to the HBV and HCV infection, about 55% hepatocellular carcinoma patients happened in China. Among them, only 10% patients can be diagnosed in early stage. Sorafenib increased PFS and OS in advanced hepatocellular carcinoma patients with liver function of Child-Pugh class A patients, but the result for Child-Pugh… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- Sorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2013to 30 Jul 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pathological or cytological confirmed advanced hepatocellular carcinoma
- 18 years to 80 years
- liver function Child-Pugh class B
- BCLC stage B or C
- estimated life time 2 months or longer
Who cannot join
- previous target therapy
- allergy to Sorafenib
- Uncontrolled Bleeding or diarrhea
- eligible for locoregional treatment
Trial locations and contacts
1 site in 1 country.
China1 site
Qingdao Central Hospital, Qingdao Cancer Hospital
Qingdao, Shandong, 266042
About this study
Official title: Phase 2 Study of Sorafenib in the Management of Liver Function Impaired Advanced Hepatocellular Carcinoma
Due to the HBV and HCV infection, about 55% hepatocellular carcinoma patients happened in China. Among them, only 10% patients can be diagnosed in early stage. Sorafenib increased PFS and OS in advanced hepatocellular carcinoma patients with liver function of Child-Pugh class A patients, but the result for Child-Pugh class B patients is unclear.
- Conditions
- Liver Cancer
- Being tested
- Sorafenib, Best Supportive Care
- Keywords
- Sorafenib, Hepatocellular carcinoma, Best supportive care, Survival
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
Also called Nexavar
Best Supportive CareOther
| Study group | Role | What they receive |
|---|---|---|
| sorafenib | Experimental | sorafenib 400mg, oral, twice a day until disease progression defined by RECIST. Receives: Drug: Sorafenib; Other: Best Supportive Care |
| Best Supportive Care | Active comparator | treatment mainly on nutrition and symptoms control Receives: Other: Best Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival and overall survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause up to 12 months
Secondary outcomes (1)
response rate
Measured: every 4 weeks till progression, total up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study start1 Aug 2013
- Primary completion30 Jan 2016
- Study completion30 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- 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
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qingdao Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youxin Ji, Qingdao Central Hospital
- Investigators
- ketao lan, M.D., Study director, Qingdao Health Bereau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932385
- Sponsor's protocol ID
- QCH20130823
- Status last verified
- Oct 2015
- First submitted
- 22 Aug 2013
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Sorafenib in the Management of Liver Function Impaired Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01932385
- Acronym / sponsor ID
- QCH20130823
- Conditions
- Liver Cancer
- Keywords
- Sorafenib, Hepatocellular carcinoma, Best supportive care, Survival
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Qingdao Central HospitalUniversity, hospital or other
- Study start
- 1 Aug 2013
- Primary completion
- 30 Jan 2016 (actual)
- Study completion
- 30 Jul 2016 (actual)
- First posted
- 30 Aug 2013 (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.
Due to the HBV and HCV infection, about 55% hepatocellular carcinoma patients happened in China. Among them, only 10% patients can be diagnosed in early stage. Sorafenib increased PFS and OS in advanced hepatocellular carcinoma patients with liver function of Child-Pugh class A patients, but the result for Child-Pugh class B patients is unclear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sorafenib | Experimental | Drug: Sorafenib, Other: Best Supportive Caresorafenib 400mg, oral, twice a day until disease progression defined by RECIST. |
| Best Supportive Care | Active comparator | Other: Best Supportive Caretreatment mainly on nutrition and symptoms control |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- pathological or cytological confirmed advanced hepatocellular carcinoma
- 18 years to 80 years
- liver function Child-Pugh class B
- BCLC stage B or C
- estimated life time 2 months or longer
Key exclusion criteria (4 listed)
- previous target therapy
- allergy to Sorafenib
- Uncontrolled Bleeding or diarrhea
- eligible for locoregional treatment
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 |
|---|---|---|
| SorafenibAlso: Nexavar | Drug | sorafenib |
| Best Supportive Care | Other | Best Supportive Care, sorafenib |
Primary outcome
progression free survival and overall survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause up to 12 months
1 secondary outcome
response rate
Time frame: every 4 weeks till progression, total up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
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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.
ketao lan, M.D. study director
Qingdao Health Bereau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sorafenib in people with Liver Cancer, run by Qingdao Central Hospital at 1 site in China.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival and overall survival (time frame: From date of randomization until the date of first documented progression or date of death from any cause 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 14 Feb 2018.