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Clinical Study of Sorafenib and Zoledronic Acid to Treat Advanced HCC

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Sorafenib and Zoledronic Acid
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, Sorafenib, Zoledronic Acid, toxic reaction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Liver Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sorafenib and Zoledronic Acid

Arm Description

Outcomes

Primary Outcome Measures

numbers of adverse events
to evaluate the toxicity of sorafenib in combination with zoledronic acid

Secondary Outcome Measures

Overall survival (OS), time to progression (TTP)
to evaluate the efficacy of sorafenib in combination with zoledronic acid

Full Information

First Posted
December 13, 2010
Last Updated
April 13, 2011
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT01259193
Brief Title
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

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
July 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Fudan University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular Carcinoma, Sorafenib, Zoledronic Acid, toxic reaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sorafenib and Zoledronic Acid
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sorafenib and Zoledronic Acid
Intervention Description
Sorafenib ,tablet,400mg Bid ,until patient can not tolerance Zoledronic Acid ,powder for injection,4mg per 3 week for 1 year
Primary Outcome Measure Information:
Title
numbers of adverse events
Description
to evaluate the toxicity of sorafenib in combination with zoledronic acid
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Overall survival (OS), time to progression (TTP)
Description
to evaluate the efficacy of sorafenib in combination with zoledronic acid
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zheng-Gang Ren, Ph.D
Phone
0086-021-64041990
Ext
2149
Email
ren.zhenggang@zs-hospital.sh.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Lan Zhang, Master
Phone
0086-021-64041990
Ext
2171
Email
zhang.lan@zs-hospital.sh.cn
Facility Information:
Facility Name
Liver Cancer Institute
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zheng-Gang Ren, Ph.D
Phone
0086-021-64041990
Ext
2137
Email
ren.zhenggang@zs-hospital.sh.cn
First Name & Middle Initial & Last Name & Degree
Lan Zhang, Master
Phone
0086-021-64041990
Ext
2171
Email
zhang.lan@zs-hospital.sh.cn
First Name & Middle Initial & Last Name & Degree
Zheng-Gang Ren, Ph.D
First Name & Middle Initial & Last Name & Degree
Jubo Zhang, PhD

12. IPD Sharing Statement

Learn more about this trial

Clinical Study of Sorafenib and Zoledronic Acid to Treat Advanced HCC

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