Clinical Study of Sorafenib and Zoledronic Acid to Treat Advanced HCC

Hepatocellular Carcinoma Clinical Trial

Official title:

Phase II Study of Sorafenib and Zoledronic Acid in Advanced HCC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01259193
• Other study ID #: SRFB-021
• Secondary ID: LCI-10-10-20
• Status: Recruiting
• Phase: Phase 2
• First received: December 13, 2010
• Last updated: April 13, 2011
• Start date: October 2010
• Est. completion date: July 2012

Study information

• Verified date: October 2010
• Source: Fudan University
• Contact: Zheng-Gang Ren, Ph.D
• Phone: 0086-021-64041990
• Email: ren.zhenggang[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 ß-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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Sorafenib and Zoledronic Acid
Sorafenib ,tablet,400mg Bid ,until patient can not tolerance Zoledronic Acid ,powder for injection,4mg per 3 week for 1 year

Locations

Country	Name	City	State
China	Liver Cancer Institute	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	numbers of adverse events	to evaluate the toxicity of sorafenib in combination with zoledronic acid	1 year	Yes
Secondary	Overall survival (OS), time to progression (TTP)	to evaluate the efficacy of sorafenib in combination with zoledronic acid	1 year	Yes

External Links

•   Zhongshan Hospital,Fudan University,Shanghai,China