HR Versus RFA for Early Stage HCC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2022-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatocellular Carcinoma Liver Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hepatic resection

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

Group Type ACTIVE_COMPARATOR

Hepatic resection

Intervention Type OTHER

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

Radiofrequency ablation

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

Group Type EXPERIMENTAL

Radiofrequency ablation

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Radiofrequency ablation

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No