NCT03097848

Brief Summary

Radiofrequency ablation is a popular treatment for recurrent hepatocellular carcinoma (HCC),but still has a higher recurrence. Sorafenib as neo-adjuvant therapy in combination of RFA was not reported yet. There's a theoretical advantage of this combination. Hence in this study the efficacy and safety of pre-administrative Sorafenib and Latter radiofrequency ablation (RFA) in Recurrent HCC will be tested in a multicenter prospective cohort study.

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
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

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

First Submitted

Initial submission to the registry

March 21, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

May 4, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

May 8, 2017

Status Verified

March 1, 2017

Enrollment Period

1.7 years

First QC Date

March 21, 2017

Last Update Submit

May 4, 2017

Conditions

HCC

Outcome Measures

Primary Outcomes (1)

  • Disease free survival

    1 year Disease free survival

    1 year

Secondary Outcomes (5)

  • Time To Recurrence

    3 year

  • Overall Survival

    3 year

  • postoperative complications

    6 months

  • Health economics index

    3 years

  • mortality

    3 months

Study Arms (2)

Sorafenib+RFA group

EXPERIMENTAL

for eligible cases, combination treatment with RFA and Sorafenib will be given.That is sorafenib for 2 week,then radiofrequency ablation

Procedure: RFADrug: Sorafenib

RFA group

ACTIVE COMPARATOR

for eligible cases, RFA will be given only.

Procedure: RFA

Interventions

RFAPROCEDURE

for eligible cases, radiofrequency ablation will be given only.

Also known as: control group
RFA groupSorafenib+RFA group
SorafenibDRUG

for eligible cases, combination treatment with RFA and Sorafenib will be given.That is sorafenib for 2 week,then radiofrequency ablation

Also known as: experimental group
Sorafenib+RFA group

Eligibility Criteria

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

You may qualify if:

  • Aged from 18 to 75 years old
  • Without gender restriction
  • With a favorable liver function of Child-Pugh A to B
  • No contraindications to RFA and anesthesia
  • Diagnosed with Recurrent HCC
  • Signed informed consent.

You may not qualify if:

  • Cancer thrombosis in major vessels/ extrahepatic metastasis
  • Uncontrollable ascites or variceal bleeding
  • Impairment in liver function
  • Severe disorders in vital organ
  • Accompanied with other tumors or infectious disease except hepatitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

MeSH Terms

Interventions

Control GroupsSorafenib

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsPhenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Central Study Contacts

Xiaobin Feng

CONTACT

+86-2368765297fengxiaobin200708@aliyun.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 21, 2017

First Posted

March 31, 2017

Study Start

May 4, 2017

Primary Completion

December 30, 2018

Study Completion

December 31, 2018

Last Updated

May 8, 2017

Record last verified: 2017-03

Locations

CN(1)