NCT01932385

Brief Summary

Due to the HBV and HCV infection, about 55% hepatocellular carcinoma patients happened in China. Among them, only 10% patients can be diagnosed in early stage. Sorafenib increased PFS and OS in advanced hepatocellular carcinoma patients with liver function of Child-Pugh class A patients, but the result for Child-Pugh class B patients is unclear.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 30, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2016

Completed
Last Updated

February 14, 2018

Status Verified

October 1, 2015

Enrollment Period

2.5 years

First QC Date

August 22, 2013

Last Update Submit

February 13, 2018

Conditions

Liver Cancer

Keywords

SorafenibHepatocellular carcinomaBest supportive careSurvival

Outcome Measures

Primary Outcomes (1)

  • progression free survival and overall survival

    From date of randomization until the date of first documented progression or date of death from any cause up to 12 months

Secondary Outcomes (1)

  • response rate

    every 4 weeks till progression, total up to 12 months

Study Arms (2)

sorafenib

EXPERIMENTAL

sorafenib 400mg, oral, twice a day until disease progression defined by RECIST.

Drug: SorafenibOther: Best Supportive Care

Best Supportive Care

ACTIVE COMPARATOR

treatment mainly on nutrition and symptoms control

Other: Best Supportive Care

Interventions

SorafenibDRUG
Also known as: Nexavar
sorafenib
Best Supportive CareOTHER
Best Supportive Caresorafenib

Eligibility Criteria

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

You may qualify if:

  • pathological or cytological confirmed advanced hepatocellular carcinoma
  • years to 80 years
  • liver function Child-Pugh class B
  • BCLC stage B or C
  • estimated life time 2 months or longer

You may not qualify if:

  • previous target therapy
  • allergy to Sorafenib
  • Uncontrolled Bleeding or diarrhea
  • eligible for locoregional treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qingdao Central Hospital, Qingdao Cancer Hospital

Qingdao, Shandong, 266042, China

Location

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

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

Study Officials

  • ketao lan, M.D.

    Qingdao Health Bereau

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Department of Oncology

Study Record Dates

First Submitted

August 22, 2013

First Posted

August 30, 2013

Study Start

August 1, 2013

Primary Completion

January 30, 2016

Study Completion

July 30, 2016

Last Updated

February 14, 2018

Record last verified: 2015-10

Locations

CN(1)