NCT01259193

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Oct 2010

Shorter than P25 for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

April 14, 2011

Status Verified

October 1, 2010

Enrollment Period

9 months

First QC Date

December 13, 2010

Last Update Submit

April 13, 2011

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular CarcinomaSorafenibZoledronic Acidtoxic reaction

Outcome Measures

Primary Outcomes (1)

  • numbers of adverse events

    to evaluate the toxicity of sorafenib in combination with zoledronic acid

    1 year

Secondary Outcomes (1)

  • Overall survival (OS), time to progression (TTP)

    1 year

Study Arms (1)

Sorafenib and Zoledronic Acid

EXPERIMENTAL
Drug: Sorafenib and Zoledronic Acid

Interventions

Sorafenib and Zoledronic AcidDRUG

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

Sorafenib and Zoledronic Acid

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liver Cancer Institute

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

SorafenibZoledronic Acid

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingDiphosphonatesOrganophosphonatesOrganophosphorus CompoundsImidazolesAzoles

Central Study Contacts

Zheng-Gang Ren, Ph.D

CONTACT

0086-021-64041990ren.zhenggang@zs-hospital.sh.cn

Lan Zhang, Master

CONTACT

0086-021-64041990zhang.lan@zs-hospital.sh.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 13, 2010

First Posted

December 14, 2010

Study Start

October 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2012

Last Updated

April 14, 2011

Record last verified: 2010-10

Locations

CN(1)