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Clinical Study of Sorafenib and Zoledronic Acid to Treat Advanced HCC

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by Fudan University.
Recruitment status was:  Recruiting
Information provided by:
Fudan University Identifier:
First received: December 13, 2010
Last updated: April 13, 2011
Last verified: October 2010

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.

Condition Intervention Phase
Hepatocellular Carcinoma Drug: Sorafenib and Zoledronic Acid Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Sorafenib and Zoledronic Acid in Advanced HCC

Resource links provided by NLM:

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • numbers of adverse events [ Time Frame: 1 year ]
    to evaluate the toxicity of sorafenib in combination with zoledronic acid

Secondary Outcome Measures:
  • Overall survival (OS), time to progression (TTP) [ Time Frame: 1 year ]
    to evaluate the efficacy of sorafenib in combination with zoledronic acid

Estimated Enrollment: 50
Study Start Date: October 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sorafenib and Zoledronic Acid 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


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01259193

Contact: Zheng-Gang Ren, Ph.D 0086-021-64041990 ext 2149
Contact: Lan Zhang, Master 0086-021-64041990 ext 2171

China, Shanghai
Liver Cancer Institute Recruiting
Shanghai, Shanghai, China, 200032
Contact: Zheng-Gang Ren, Ph.D    0086-021-64041990 ext 2137   
Contact: Lan Zhang, Master    0086-021-64041990 ext 2171   
Principal Investigator: Zheng-Gang Ren, Ph.D         
Sub-Investigator: Jubo Zhang, PhD         
Sponsors and Collaborators
Fudan University
  More Information

Responsible Party: Ren Zhenggang/Professor Sun Huichuan/Professor, Shanghai Zhongshan Hospital,China Identifier: NCT01259193     History of Changes
Other Study ID Numbers: SRFB-021
Study First Received: December 13, 2010
Last Updated: April 13, 2011

Keywords provided by Fudan University:
Hepatocellular Carcinoma
Zoledronic Acid
toxic reaction

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Zoledronic acid
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on September 21, 2017