NCT01415063

Brief Summary

The combination of transcatheter arterial chemoembolization (TACE) with RFA has also reported to be an effective treatment for HCC. Studies have shown TACE combined RFA to have better efficacy than RFA for medium-sized HCC (3-5 cm) and multiple-tumor HCC, but not for small HCC (≤3 cm). However, to our knowledge, there have not been any prospective studies to assess whether TACE combined sequentially with RFA is more effective than RFA alone for the treatment of HCC recurrence after curative treatment. We hypothesized that the combination of TACE and RFA might result in better patient survival than RFA alone. Thus, the purpose of this study was to prospectively compare the effects of sequential TACE-RFA with RFA alone for the treatment of recurrent HCC. Recurrent HCC in this study was defined as new tumors in the remnant liver, distant from the resection or ablation site after curative treatment of RFA or hepatectomy.

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
120

participants targeted

Target at P50-P75 for phase_4 hepatocellular-carcinoma

Timeline
Completed

Started Feb 2011

Typical duration for phase_4 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

February 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

August 11, 2011

Status Verified

February 1, 2011

Enrollment Period

2.1 years

First QC Date

August 10, 2011

Last Update Submit

August 10, 2011

Conditions

Hepatocellular CarcinomaRFATACE

Keywords

Hepatocellular CarcinomaRFATACE

Outcome Measures

Primary Outcomes (1)

  • overall survival

    1 year

Secondary Outcomes (1)

  • disease-free survival

    1 year

Study Arms (2)

RFA

EXPERIMENTAL

For RFA, we used a commercially available system with a 375-KHz computer-assisted radiofrequency generator (Elektrotom HiTT 106, Berchtold, Medizinelektronik, Germany) and an open-perfused electrode (Berchtold, Tuttlingen, Germany) of 15 cm (or 20 cm), 14 Ga, and a 15 mm (or 20 mm) active electrode tip with microbores.

Procedure: TACE-RFA

TACE-RFA

EXPERIMENTAL

TACE first, then RFA within 2 weeks

Procedure: RFA

Interventions

RFAPROCEDURE

For RFA, we used a commercially available system with a 375-KHz computer-assisted radiofrequency generator (Elektrotom HiTT 106, Berchtold, Medizinelektronik, Germany) and an open-perfused electrode (Berchtold, Tuttlingen, Germany) of 15 cm (or 20 cm), 14 Ga, and a 15 mm (or 20 mm) active electrode tip with microbores.

TACE-RFA
TACE-RFAPROCEDURE

TACE first, then RFA within 2 weeks

RFA

Eligibility Criteria

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

You may qualify if:

  • age 18 - 75 years;
  • Distant recurrence of HCC after initial curative treatment (including initial RFA or hepatectomy);
  • no other treatment received except for the initial RFA or hepatectomy;
  • Single tumor less than 4cm in diameter;
  • lesions visible on ultrasound and with an acceptable and safe path between the lesion and the skin as shown on ultrasound;
  • no severe coagulation disorders (prothrombin activity \< 40% or a platelet count of \< 40,000 / mm3;
  • Eastern Co-operative Oncology Group performance(ECOG) status 0 -

You may not qualify if:

  • the presence of vascular invasion or extrahepatic spread on imaging;
  • a Child-Pugh class C liver cirrhosis or evidence of hepatic decompensation including ascites, severe coagulation disorders (prothrombin activity \< 40% or a platelet count of \< 40,000 / mm3), esophageal or gastric variceal bleeding or hepatic encephalopathy;
  • an American Society of Anesthesiologists (ASA) score ≥ 3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Center, Sun Yat-set University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 10, 2011

First Posted

August 11, 2011

Study Start

February 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2014

Last Updated

August 11, 2011

Record last verified: 2011-02

Locations

CN(1)