NCT00999843

Brief Summary

Patients with liver cancer will receive interventional therapy plus radiotherapy. Maintenance Sorafenib will be taken after the completion of radiotherapy. Hypothesis of the current study is that Sorafenib as a maintenance therapy is safe and superior to radiotherapy combined with interventional therapy in terms of survival in comparison to historical data.

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
30

participants targeted

Target at P50-P75 for phase_1 hepatocellular-carcinoma

Timeline
Completed

Started Oct 2009

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, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

October 22, 2009

Status Verified

October 1, 2009

Enrollment Period

1 year

First QC Date

October 21, 2009

Last Update Submit

October 21, 2009

Conditions

Hepatocellular Carcinoma

Keywords

SorafenibThree-dimensional conformal radiation therapyIntensity-modulated radiation therapyTranscatheter arterial chemoembolization

Outcome Measures

Primary Outcomes (1)

  • The safety and tolerability of maintenance Sorafenib.

    twelve months

Secondary Outcomes (1)

  • Time to progression (TTP), progression-free survival (PFS) and overall survival (OS)

    30 months

Interventions

SorafenibDRUG

Sorafenib is administered only to the patients with non-progression disease (CR, PR and SD) 4 weeks after the completion of radiotherapy. The dose is 400 mg, p.o., twice a day. Sorafenib is continuously given for 12 months unless intolerable toxicities and/or tumor progression.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of equal or older than 18 years and not over 75 years with a life expectancy of at least 12 weeks;
  • Karnofsky performance status (KPS) of ≥70;
  • Histologically or cytologically confirmed HCC;
  • BCLC stage B, solitary lesion (bigger than 5 cm in diameter) with tumor burden less than 50% of total liver volume;
  • Liver function of Child-Pugh A;
  • Technically unresectable, medically inoperable, or surgery declined by the patient;
  • Normal renal function and adequate bone marrow reservation;
  • Signed informed consent must be obtained prior to any study specific procedure.

You may not qualify if:

  • Presence of intrahepatic and/or extrahepatic metastases
  • Previous received systemic therapy for liver cancer;
  • History of radiotherapy to the liver;
  • Indistinct tumor boundary on CT/MRI images;
  • Previous or concurrent malignancies, with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix or superficial bladder tumors \[Ta, Tis and T1\];
  • History of cardiac disease: congestive heart failure \> NYHA class 2, active CAD, cardiac arrythmias requiring anti-arrhythmic therapy or uncontrolled hypertension within the last 12 months;
  • Concurrent uncontrolled medical conditions;
  • Pregnancy or breast feeding;
  • Investigational drug therapy outside of this trial during or within 4 weeks of study entry;
  • Psychiatric or medical unstable conditions that compromise the patient's ability to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

  • Zhao JD, Liu J, Ren ZG, Gu K, Zhou ZH, Li WT, Chen Z, Xu ZY, Liu LM, Jiang GL. Maintenance of Sorafenib following combined therapy of three-dimensional conformal radiation therapy/intensity-modulated radiation therapy and transcatheter arterial chemoembolization in patients with locally advanced hepatocellular carcinoma: a phase I/II study. Radiat Oncol. 2010 Feb 12;5:12. doi: 10.1186/1748-717X-5-12.

    PMID: 20149262DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib

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-Ring

Study Officials

  • Guo-liang Jiang, M.D.

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian-dong Zhao, M.D.

CONTACT

862164175590neilzhaojiandong@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 21, 2009

First Posted

October 22, 2009

Study Start

October 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2012

Last Updated

October 22, 2009

Record last verified: 2009-10

Locations

CN(1)