Clinical Study of Sorafenib and Zoledronic Acid to Treat Advanced HCC

Fudan University

Status and phase

Unknown

Phase 2

Conditions

Hepatocellular Carcinoma

Treatments

Drug: Sorafenib and Zoledronic Acid

Study type

Interventional

Funder types

Other

Identifiers

NCT01259193

LCI-10-10-20

SRFB-021

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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