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

Primary Purpose

Hepatocellular Carcinoma, Liver Cancer

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Hepatic resection

Radiofrequency ablation

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, Liver Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Hepatic resection

Radiofrequency ablation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall survivals

Secondary Outcome Measures

Recurrence rates

Full Information

NCT ID

NCT02169765

First Posted

June 18, 2014

Last Updated

July 21, 2020

Sponsor

Guangxi Medical University

1. Study Identification

Unique Protocol Identification Number

NCT02169765

Brief Title

HR Versus RFA for Early Stage HCC

Acronym

ARTC-HCC

Official Title

Hepatic Resection Versus Radiofrequency Ablation for Early-stage Hepatocellular Carcinoma: a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2020 (Anticipated)

Primary Completion Date

December 20, 2022 (Anticipated)

Study Completion Date

December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guangxi Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma, Liver Cancer

Keywords

Hepatocellular Carcinoma, Liver Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hepatic resection

Arm Type

Active Comparator

Arm Description

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

Arm Title

Radiofrequency ablation

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Hepatic resection

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Radiofrequency ablation

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall survivals

Time Frame

5-years

Secondary Outcome Measure Information:

Title

Recurrence rates

Time Frame

5-years

Other Pre-specified Outcome Measures:

Title

morbidity

Time Frame

30,90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jian-Hong Zhong, MD

Phone

86-771-5330855

zhongjianhong66@163.com

Facility Information:

Facility Name

Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University

City

Nanning

State/Province

Guangxi

ZIP/Postal Code

530021

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jian-Hong Zhong, MD

Phone

86-771-5330855

zhongjianhong66@163.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

21679247

Citation

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.

Results Reference

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PubMed Identifier

23603669

Citation

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.

Results Reference

background

PubMed Identifier

23941614

Citation

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.

Results Reference

background

PubMed Identifier

24404166

Citation

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.

Results Reference

background

PubMed Identifier

20099299

Citation

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.

Results Reference

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HR Versus RFA for Early Stage HCC

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