Clinical Study of Sorafenib and Zoledronic Acid to Treat Advanced HCC

April 13, 2011 updated by: Fudan University

Phase II Study of Sorafenib and Zoledronic Acid in Advanced HCC

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Liver Cancer Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zheng-Gang Ren, Ph.D
        • Sub-Investigator:
          • Jubo Zhang, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
numbers of adverse events
Time Frame: 1 year
to evaluate the toxicity of sorafenib in combination with zoledronic acid
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS), time to progression (TTP)
Time Frame: 1 year
to evaluate the efficacy of sorafenib in combination with zoledronic acid
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

July 1, 2011

Study Completion (Anticipated)

July 1, 2012

Study Registration Dates

First Submitted

December 13, 2010

First Submitted That Met QC Criteria

December 13, 2010

First Posted (Estimate)

December 14, 2010

Study Record Updates

Last Update Posted (Estimate)

April 14, 2011

Last Update Submitted That Met QC Criteria

April 13, 2011

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRFB-021
  • LCI-10-10-20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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