Status:
UNKNOWN
Clinical Study of Sorafenib and Zoledronic Acid to Treat Advanced HCC
Lead Sponsor:
Fudan University
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01259193
Start Date
October 1 2010
End Date
July 1 2012
Last Update
April 14 2011
Active Locations (1)
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1
Liver Cancer Institute
Shanghai, Shanghai Municipality, China, 200032