Hepatocellular CarcinomaPhase 2NCT01259193
Clinical Study of Sorafenib and Zoledronic Acid to Treat Advanced HCC
A Phase 2 study testing Sorafenib and Zoledronic Acid in people with Hepatocellular Carcinoma, run by Fudan University at 1 site in China.
Trial summary
Sorafenib ,an oral multikinase inhibitor targeting several tyrosine-kinase receptors with antiangiogenesis and antiproliferation of HCC, is the first approved target therapy for HCC. Zoledronic acid is used for treatment of bone metastasis of diverse malignant cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Sorafenib and Zoledronic Acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Oct 2010to Jul 2012
- Phase
- Phase 2
- 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
- Age ≥ 18 years
- Hepatocellular carcinoma confirmed with pathology or identified with radiological images with typical features
- patient with unresectable primary hepatocellular carcinoma
- Child-Pugh Class A or B, score ≤ 7
- ECOG score 0-2
- Expected survival time not less than 12 weeks
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- At least one tumor nodule with one uni-dimension of ≥ 1 cm
- Peripheral platelet of or more than 50×10(9)/L
- Peripheral hemoglobin of or more than 85g/L
- Peripheral albumen of or more than 28g/L
- Total bilirubin ≤3.0mg/dl
- ALT and AST ≤ 5.0 x the upper limit of normal
- Serum amylase ≤ 1.5x the upper limit of normal
- Serum creatinine ≤ 1.5x upper limit of normal
- PT-INR<2.3 or PT prolong no more than 4s of normal
Who cannot join
- Congestive heart failure > NYHA class 2
- History of active coronary disease( except myocardial infarction more than 6 months ago)
- Receive anti-arrhythmia treatment(except β-receptor blocker,calcium channel blocker and digoxin)
- uncontrollable hypertension
- Active clinically serious infections (> 2 NCI-CTC Version 3.0)
- History of HIV infection
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- Inclined to hemorrhage or active hemorrhage with 1 month
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in this study
- Pregnant or breast-feeding.Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to enrolling in this portion of the study
- Known or suspected allergy to any agent given in association with this trial
- Concomitant anti-cancer therapy (except immunotherapy and Chinese traditional treatment)
- Surgical operation within 4 weeks prior to enrolling in this portion of the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Liver Cancer Institute
Shanghai, Shanghai Municipality, 200032
Zheng-Gang Ren, Ph.D, 0086-021-64041990 ext. 2137, ren.zhenggang@zs-hospital.sh.cn
Lan Zhang, Master, 0086-021-64041990 ext. 2171, zhang.lan@zs-hospital.sh.cn
About this study
Official title: Phase II Study of Sorafenib and Zoledronic Acid in Advanced HCC
Sorafenib ,an oral multikinase inhibitor targeting several tyrosine-kinase receptors with antiangiogenesis and antiproliferation of HCC, is the first approved target therapy for HCC.
Zoledronic acid is used for treatment of bone metastasis of diverse malignant cancer. Emerging data suggest that zoledronic acid may also exhibit anticancer properties.
The objectives of the study is to evaluate the safety of Sorafenib combined with Zoledronic Acid and to evaluate overall survival and time to progression.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Sorafenib and Zoledronic Acid
- Keywords
- Hepatocellular Carcinoma, Sorafenib, Zoledronic Acid, toxic reaction
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorafenib and Zoledronic AcidDrug
Sorafenib ,tablet,400mg Bid ,until patient can not tolerance Zoledronic Acid ,powder for injection,4mg per 3 week for 1 year
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib and Zoledronic Acid | Experimental | Not described Receives: Drug: Sorafenib and Zoledronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
numbers of adverse events
to evaluate the toxicity of sorafenib in combination with zoledronic acid
Measured: 1 year
Secondary outcomes (1)
Overall survival (OS), time to progression (TTP)
to evaluate the efficacy of sorafenib in combination with zoledronic acid
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionJul 2011 (estimated)
- Study completionJul 2012 (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 Fudan UniversityThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259193
- Sponsor's protocol ID
- SRFB-021
- Other IDs
- LCI-10-10-20
- Status last verified
- Oct 2010
- First submitted
- 13 Dec 2010
- Last updated
- 14 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Sorafenib and Zoledronic Acid in Advanced HCC
- ClinicalTrials.gov ID
- NCT01259193
- Acronym / sponsor ID
- SRFB-021
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Sorafenib, Zoledronic Acid, toxic reaction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 14 Dec 2010 (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.
Sorafenib ,an oral multikinase inhibitor targeting several tyrosine-kinase receptors with antiangiogenesis and antiproliferation of HCC, is the first approved target therapy for HCC.
Zoledronic acid is used for treatment of bone metastasis of diverse malignant cancer. Emerging data suggest that zoledronic acid may also exhibit anticancer properties.
The objectives of the study is to evaluate the safety of Sorafenib combined with Zoledronic Acid and to evaluate overall survival and time to progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sorafenib and Zoledronic Acid | Experimental | Drug: Sorafenib and Zoledronic Acid |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥ 18 years
- Hepatocellular carcinoma confirmed with pathology or identified with radiological images with typical features
- patient with unresectable primary hepatocellular carcinoma
- Child-Pugh Class A or B, score ≤ 7
- ECOG score 0-2
Key exclusion criteria (12 listed)
- Congestive heart failure > NYHA class 2
- History of active coronary disease( except myocardial infarction more than 6 months ago)
- Receive anti-arrhythmia treatment(except β-receptor blocker,calcium channel blocker and digoxin)
- uncontrollable hypertension
- Active clinically serious infections (> 2 NCI-CTC Version 3.0)
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 |
|---|---|---|
| Sorafenib and Zoledronic AcidSorafenib ,tablet,400mg Bid ,until patient can not tolerance Zoledronic Acid ,powder for injection,4mg per 3 week for 1 year | Drug | Sorafenib and Zoledronic Acid |
Primary outcome
numbers of adverse events
Time frame: 1 year
to evaluate the toxicity of sorafenib in combination with zoledronic acid
1 secondary outcome
Overall survival (OS), time to progression (TTP)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sorafenib and Zoledronic Acid in people with Hepatocellular Carcinoma, run by Fudan University 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 15 inclusion and 12 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 14 Apr 2011. 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 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.
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 Zheng-Gang Ren, Ph.D (0086-021-64041990 ext. 2149, ren.zhenggang@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numbers of adverse events (time frame: 1 year). 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 Apr 2011.