Clinical Study of Sorafenib and Zoledronic Acid to Treat Advanced HCC

Study Overview
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Brief Summary
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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.

Official Title
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Phase II Study of Sorafenib and Zoledronic Acid in Advanced HCC

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: Sorafenib and Zoledronic Acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sorafenib and Zoledronic Acid<br> | Drug: Sorafenib and Zoledronic Acid<br>* Sorafenib ,tablet,400mg Bid ,until patient can not tolerance Zoledronic Acid ,powder for injection,4mg per 3 week for 1 year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| numbers of adverse events | to evaluate the toxicity of sorafenib in combination with zoledronic acid | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS), time to progression (TTP) | to evaluate the efficacy of sorafenib in combination with zoledronic acid | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular Carcinoma, Sorafenib, Zoledronic Acid, toxic reaction