NCT00822562

Brief Summary

In this study, we intend to divide the subjects who have been confirmed recurrent HCC into two groups: Group A: treatment with pure surgery or Group B: treatment with pure radio frequency. We will compare the non-tumor survival time, long-term survival rate between the two groups, summarize the merits and demerits of both groups, and try to establish a standardized therapy and treatment for the this kind of patients through prospective studies on the molecular biological difference of pathological samples between the first and second surgeries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Jan 2009

Shorter than P25 for not_applicable hepatocellular-carcinoma

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

January 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 14, 2009

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 1, 2016

Status Verified

March 1, 2016

Enrollment Period

Same day

First QC Date

January 6, 2009

Last Update Submit

March 30, 2016

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinomasurgery

Outcome Measures

Primary Outcomes (1)

  • Overall survival rate

    two years

Secondary Outcomes (1)

  • non-tumor life span, intra-liver recurrence rate, metastasis rate

    two years

Study Arms (2)

Procedure/Surgery

ACTIVE COMPARATOR

surgery

Procedure: surgery

Procedure

EXPERIMENTAL

PRFA or PMCT

Other: PRFA or PMCT

Interventions

PRFA or PMCTOTHER

PRFA or PMCT 30-35W for 10-15minutes one cycle,three cycles

Procedure
surgeryPROCEDURE

only surgery

Procedure/Surgery

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \~60 years old;
  • diagnosed HCC pathologically, and confirmed recurrent HCC through ultrasonic B, CT, MRI or DSA test;
  • has a good condition in vital organs such as heart, lung, and kidney;
  • has a good liver function: Child A level, or nearly A level after hepatoprotection treatment;
  • solitary small cancer focus (diameter \<5cm), or the number of recurrent HCC focus is no more than three and all of them grow in the same lobe of liver;
  • without jaundice (not including jaundice in the bile ducts), without ascites or extensive metastasis outside the liver;
  • without invasion to portal vein.

You may not qualify if:

  • subjects refuse to participate in this study;
  • subjects cannot be followed up regularly;
  • subjects with severe heart, lung, kidney diseases;
  • subjects with liver CP level B or C, and serum creatinine ≥2×ULN;
  • subjects with severe bone marrow depression, such as neutrophil counting is lower than 1.5 × 109.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, 200438, China

Location

Related Publications (1)

  • Xia Y, Li J, Liu G, Wang K, Qian G, Lu Z, Yang T, Yan Z, Lei Z, Si A, Wan X, Zhang H, Gao C, Cheng Z, Pawlik TM, Wang H, Lau WY, Wu M, Shen F. Long-term Effects of Repeat Hepatectomy vs Percutaneous Radiofrequency Ablation Among Patients With Recurrent Hepatocellular Carcinoma: A Randomized Clinical Trial. JAMA Oncol. 2020 Feb 1;6(2):255-263. doi: 10.1001/jamaoncol.2019.4477.

    PMID: 31774468DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Study Officials

  • Feng Shen, MD

    Eastern Hepatobiliary Surgery Hospital Affiliated to Second Military Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice president of the Eastern Hepatobiliary Surgery Hospotal

Study Record Dates

First Submitted

January 6, 2009

First Posted

January 14, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2009

Study Completion

December 1, 2010

Last Updated

April 1, 2016

Record last verified: 2016-03

Locations

CN(1)