Clinical Study of Sorafenib and Zoledronic Acid to Treat Advanced HCC

Phase 2

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Sorafenib and Zoledronic Acid

• Registration Number: NCT01259193
• Lead Sponsor: Fudan University

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-10
• Study Start: 2010-10
• Study First Submitted: 2010-12-13
• Study First Submitted QC: 2010-12-13
• Study First Posted: 2010-12-14
• Last Update Submitted: 2011-04-13
• Last Update Posted: 2011-04-14
• Primary Completion: 2011-07
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sorafenib and Zoledronic Acid	Sorafenib and Zoledronic Acid	-

Primary Outcome Measures

Name	Time	Method
numbers of adverse events	1 year	to evaluate the toxicity of sorafenib in combination with zoledronic acid

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS), time to progression (TTP)	1 year	to evaluate the efficacy of sorafenib in combination with zoledronic acid

Trial Locations

Locations (1)

Liver Cancer Institute; 🇨🇳 Shanghai, Shanghai, China