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HR Versus RFA for Early Stage HCC (ARTC-HCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02169765
Recruitment Status : Not yet recruiting
First Posted : June 23, 2014
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Jian-Hong Zhong, Guangxi Medical University

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Liver Cancer Other: Hepatic resection Other: Radiofrequency ablation Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hepatic Resection Versus Radiofrequency Ablation for Early-stage Hepatocellular Carcinoma: a Randomized Controlled Trial
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : December 20, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Hepatic resection
Indications for HR were the presence of appropriate residual liver volume determined by volumetric computed tomography and lack of hepatic encephalopathy.
Other: Hepatic resection
Adequate remnant liver volume was 30% for HCC patients without cirrhosis, and >50% for HCC patients with chronic hepatitis, cirrhosis, or severe fatty liver.

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




Primary Outcome Measures :
  1. Overall survivals [ Time Frame: 5-years ]

Secondary Outcome Measures :
  1. Recurrence rates [ Time Frame: 5-years ]

Other Outcome Measures:
  1. morbidity [ Time Frame: 30,90 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169765


Contacts
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Contact: Jian-Hong Zhong, MD 86-771-5330855 zhongjianhong66@163.com

Locations
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China, Guangxi
Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University
Nanning, Guangxi, China, 530021
Contact: Jian-Hong Zhong, MD    86-771-5330855    zhongjianhong66@163.com   
Sponsors and Collaborators
Guangxi Medical University
Publications:
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Responsible Party: Jian-Hong Zhong, Affiliated Tumor Hospital, Guangxi Medical University
ClinicalTrials.gov Identifier: NCT02169765    
Other Study ID Numbers: HRRFA-HCC
HRRFA-HCC ( Registry Identifier: Jian-Hong Zhong )
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jian-Hong Zhong, Guangxi Medical University:
Hepatocellular Carcinoma
Liver Cancer
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases