Clinical trial NCT01259193: Clinical Study of Sorafenib and Zoledronic Acid to Treat Advanced HCC
Official title: Phase II Study of Sorafenib and Zoledronic Acid in Advanced HCC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
Sorafenib
Zoledronic Acid
toxic reaction
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2010-12-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: numbers of adverse events
timeFrame: 1 year
Secondary outcomes:
measure: Overall survival (OS), time to progression (TTP)
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Liver Cancer Institute
state: Shanghai
Study officials:
References: