NCT02169765

Brief Summary

Hepatocellular carcinoma (HCC) is the third leading death cancer in the world. It is important to explore a safe and effective therapy for early-stage HCC. Previous studies reported that radiofrequency ablation (RFA) has higher efficacy and is associated with fewer complications and shorter hospital stays than hepatic resection (HR) for early-stage HCC. However, meta-analysis and systematic review found that RFA is associated with higher recurrence rate and lower long-term overall survival.

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 below P25 for phase_3 hepatocellular-carcinoma

Timeline
Completed

Started Aug 2020

Shorter than P25 for phase_3 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

First Submitted

Initial submission to the registry

June 18, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
6.1 years until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

2.4 years

First QC Date

June 18, 2014

Last Update Submit

July 21, 2020

Conditions

Hepatocellular CarcinomaLiver Cancer

Keywords

Hepatocellular CarcinomaLiver Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survivals

    5-years

Secondary Outcomes (1)

  • Recurrence rates

    5-years

Other Outcomes (1)

  • morbidity

    30,90 days

Study Arms (2)

Hepatic resection

ACTIVE COMPARATOR

Indications for HR were the presence of appropriate residual liver volume determined by volumetric computed tomography and lack of hepatic encephalopathy.

Other: Hepatic resection

Radiofrequency ablation

EXPERIMENTAL

Radiofrequency ablation is performed in less than one week after clinical diagnosis.

Other: Radiofrequency ablation

Interventions

Hepatic resectionOTHER

Adequate remnant liver volume was 30% for HCC patients without cirrhosis, and \>50% for HCC patients with chronic hepatitis, cirrhosis, or severe fatty liver.

Hepatic resection
Radiofrequency ablationOTHER

Radiofrequency ablation is performed in less than one week after clinical diagnosis.

Radiofrequency ablation

Eligibility Criteria

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

You may qualify if:

  • Age 18-75 years
  • Clinical diagnosis of HCC was confirmed by histopathological examination of surgical samples in all patients
  • Tumor stage fitted into Milan Criteria
  • Patients have Child-Pugh A liver function
  • No previous neoadjuvant treatment
  • No evidence of metastasis to the lymph nodes and/or distant metastases on the basis of preoperative imaging results and perioperative findings
  • No malignancy other than HCC for 5 years prior to the initial HCC treatment
  • No history of encephalopathy, ascites refractory to diuretics or variceal bleeding

You may not qualify if:

  • History of cardiac disease:
  • Congestive heart failure \> New York Heart Association (NYHA) class 2; active coronary artery disease (myocardial infarction more than 6 months prior to study entry is permitted);
  • Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers, calcium channel blocker or digoxin; or
  • Uncontrolled hypertension (failure of diastolic blood pressure to fall below 90 mmHg, despite the use of 3 antihypertensive drugs).
  • Active clinically serious infections ( \> grade 2 National Cancer Institute \[NCI\]-Common Terminology Criteria for Adverse Events version 3.0)
  • Known history of human immunodeficiency virus (HIV) infection
  • Known Central Nervous System tumors including metastatic brain disease
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
  • History of organ allograft
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  • Known or suspected allergy to the investigational agent or any agent given in association with this trial
  • Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
  • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
  • Excluded therapies and medications, previous and concomitant:
  • Autologous bone marrow transplant or stem cell rescue within four months of start of study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University

Nanning, Guangxi, 530021, China

Location

Related Publications (5)

  • Cho YK, Rhim H, Noh S. Radiofrequency ablation versus surgical resection as primary treatment of hepatocellular carcinoma meeting the Milan criteria: a systematic review. J Gastroenterol Hepatol. 2011 Sep;26(9):1354-60. doi: 10.1111/j.1440-1746.2011.06812.x.

    PMID: 21679247BACKGROUND

  • Cucchetti A, Piscaglia F, Cescon M, Colecchia A, Ercolani G, Bolondi L, Pinna AD. Cost-effectiveness of hepatic resection versus percutaneous radiofrequency ablation for early hepatocellular carcinoma. J Hepatol. 2013 Aug;59(2):300-7. doi: 10.1016/j.jhep.2013.04.009. Epub 2013 Apr 18.

    PMID: 23603669BACKGROUND

  • Duan C, Liu M, Zhang Z, Ma K, Bie P. Radiofrequency ablation versus hepatic resection for the treatment of early-stage hepatocellular carcinoma meeting Milan criteria: a systematic review and meta-analysis. World J Surg Oncol. 2013 Aug 13;11(1):190. doi: 10.1186/1477-7819-11-190.

    PMID: 23941614BACKGROUND

  • Wang Y, Luo Q, Li Y, Deng S, Wei S, Li X. Radiofrequency ablation versus hepatic resection for small hepatocellular carcinomas: a meta-analysis of randomized and nonrandomized controlled trials. PLoS One. 2014 Jan 3;9(1):e84484. doi: 10.1371/journal.pone.0084484. eCollection 2014.

    PMID: 24404166BACKGROUND

  • Cho YK, Kim JK, Kim WT, Chung JW. Hepatic resection versus radiofrequency ablation for very early stage hepatocellular carcinoma: a Markov model analysis. Hepatology. 2010 Apr;51(4):1284-90. doi: 10.1002/hep.23466.

    PMID: 20099299BACKGROUND

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver Neoplasms

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Central Study Contacts

Jian-Hong Zhong, MD

CONTACT

86-771-5330855zhongjianhong66@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Affiliated Tumor Hospital

Study Record Dates

First Submitted

June 18, 2014

First Posted

June 23, 2014

Study Start

August 1, 2020

Primary Completion

December 20, 2022

Study Completion

December 30, 2022

Last Updated

July 22, 2020

Record last verified: 2020-07

Locations

CN(1)