Clinical Study of Sorafenib and Zoledronic Acid to Treat Advanced HCC
NCT ID: NCT01259193
Last Updated: 2011-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2010-10-31
2012-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Sorafenib and Zoledronic Acid
Sorafenib and Zoledronic Acid
Sorafenib ,tablet,400mg Bid ,until patient can not tolerance Zoledronic Acid ,powder for injection,4mg per 3 week for 1 year
Interventions
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Sorafenib and Zoledronic Acid
Sorafenib ,tablet,400mg Bid ,until patient can not tolerance Zoledronic Acid ,powder for injection,4mg per 3 week for 1 year
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Shanghai Zhongshan Hospital,China
Locations
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Liver Cancer Institute
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LCI-10-10-20
Identifier Type: -
Identifier Source: secondary_id
SRFB-021
Identifier Type: -
Identifier Source: org_study_id
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