NCT02187081

Brief Summary

Radiofrequency ablation (RFA)can be curative with small localized HCCs up to 5 cm in diameter. However, the long-term prognosis is not satisfactory due to the high incidence of recurrence.Multimodality treatments are needed to prevent recurrences，but only useful with locoregional disease. Sorafenib is an oral multi-kinase inhibitor and the only systemic drug associated with improved overall survival (OS) in patients with advanced HCC. Retrospective and randomized studies have suggested that the combined use of Sorafenib may be useful in patients with unresectable HCC. Based on these information and the multiple actions of Sorafenib, we hypothesized that Sorafenib plus RFA may be useful in patients with early to Mid term HCC. In this investigation, we evaluated the safety and efficacy of a combination Sorafenib and RFA therapy in patients with Barcelona Clinic Liver Cancer (BCLC) Stage 0 -B1 HCC 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
380

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 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

July 1, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
2.7 years until next milestone

Study Start

First participant enrolled

March 15, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

1.7 years

First QC Date

July 1, 2014

Last Update Submit

March 27, 2017

Conditions

HCC

Keywords

HCCRFASorafenibTumor recurrenceOverall survival

Outcome Measures

Primary Outcomes (1)

  • 2-year incidence of tumor recurrence

    to calculate the incidence of tumor recurrence of experiment and control group at two year after complete treatment.

    2 year

Secondary Outcomes (7)

  • Overall survival

    5 years

  • 1-year incidence of recurrence

    1-year

  • 3-year incidence of recurrence

    3 year

  • 5-year incidence of recurrence

    5 year

  • Time to progression

    average 2 years

  • +2 more secondary outcomes

Study Arms (2)

Sorafenib+RFA

EXPERIMENTAL

We give radiofrequency ablation plus Sorafenib for the treatment of HCC

Procedure: radiofrequency ablation plus Sorafenib

RFA alone

ACTIVE COMPARATOR

We give Radiofrequency ablation alone for the treatment of HCC

Procedure: Radiofrequency ablation

Interventions

radiofrequency ablation plus SorafenibPROCEDURE

To treat HCC with the combination of radiofrequency ablation and sorafenib

Sorafenib+RFA
Radiofrequency ablationPROCEDURE

To treat HCC with radiofrequency ablation alone.

RFA alone

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Authorization of Informed Consent
  • HCC diagnosed by biopsy or Image findings
  • BCLC stage 0 to B1
  • This time was the primary treatment of HCC. Had no history of any tumor specific therapy,including RFA,Hepatectomy,TACE,HIFU,and Transplantation
  • Child Pugh A or B
  • ECOG 0 to 2
  • single lesion less than or equal to 5 cm,2 to 3 nodules, maximal size less than equal to 3cm
  • Male or female (without pregnancy)
  • Ages between 18 to 70 years
  • Capable of take medicines
  • anticipate at least survival of 12 weeks
  • Unwilling to receive surgical resection or liver transplantation
  • Potentially curable disease by RFA
  • Sorafenib administrated less than 4 weeks before or after RFA procedures
  • For any excuse,subject should take Sorafenib at least for 4 weeks

You may not qualify if:

  • A cancer embolus in major hepatic vessels or extrahepatic metastases
  • Tumor number more than 4 or tumor size larger than 5 cm
  • A present or past history of uncontrollable ascites, hepatic encephalopathy or variceal bleeding
  • A history of a secondary malignancy
  • Severe dysfunction of the heart, kidney or other organs
  • Active infection except viral hepatitis
  • Any treatment history of target lesion including chemotherapy and TACE
  • Pregnancy
  • received other trials on gene therapy
  • have received operation less than 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

MeSH Terms

Conditions

Recurrence

Interventions

Radiofrequency AblationSorafenib

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativePhenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Central Study Contacts

Xiaobin Feng, Docter

CONTACT

86-23-68765297fengxiaobin200708@aliyun.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Xiaobin Feng

Study Record Dates

First Submitted

July 1, 2014

First Posted

July 10, 2014

Study Start

March 15, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 28, 2017

Record last verified: 2017-03

Locations

CN(1)