Resection Versus Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma With Solitary Huge Tumor

Study Overview
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Brief Summary
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This clinical trial aims to compare hepatectomy with Transarterial Chemoembolization (TACE) for Hepatic Cellular Cancer With Solitary Huge Tumor (≥5cm). All patients will be divided into two group.One group will receive hepatic resection, while an another equivalent group patients will be treated with Transarterial Chemoembolization.

Detailed Description
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Hepatocellular carcinoma (HCC) is the most common primary malignant tumor of the liver.For Barcelona Clinic Liver Cancer (BCLC) stage B patients，especially those with Solitary Huge Tumor (≥5cm) ，the better therapy between hepatic resection and transarterial chemoembolization remains controversial despite extensive studies。 From now on, we prospectively collected patients with solitary huge HCC who received hepatectomy or TACE. Of the 200 patients，100 patients were surgically treated and the others underwent TACE。After the treatment, patients received routine follow-up with physical examination, serum α-fetoprotein (AFP) level and ultrasonography at 3-month intervals for the first year and then every 6 months.The end of follow-up was determined as either the time of last follow-up (July 2019) or death. The overall survival，including 1, 2 and 3-year overall survival rates，will be analyse. All data are collected prospectively.

Official Title
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Resection Versus Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma With Solitary Huge Tumor: a Randomized Controlled Trial

Conditions
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Carcinoma, Hepatocellular, Survival Rate

Intervention / Treatment
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* Procedure: hepatic resection
* Procedure: TACE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Hepatic cellular Carcinoma. Patients with Solitary Huge Tumor (≥5cm）of Hepatic cellular Carcinoma (HCC) detected by Serum Alpha Fetoprotein (AFP) and CT or MRI. Patients without Hepatic vein or bile duct invasion and extrahepatic metastasis. Patients without surgical contraindication. Patients with Child A or B liver function and indocyanine green retention rate at 15min (ICGR15) < 10% before treatment. Laboratory examination: haemoglobin (Hb)>100g/L, white blood cell (WBC) > 3000/mL, blood platelet counts (PLT) > 8×10*10/L before treatment. Patients without severe esophagogastric varices before treatment. Patients with HBV，HBV DNA≤100, 000 copy/mL. All of the patients has written consent for this research. Exclusion Criteria: Patients with multiple tumors or vascular or bile duct invasion or extrahepatic metastasis. Patients with surgical contraindication. Patients with Child C grade liver function before treatment. Patients with other malignancy. .Patients treated with hepatic resection or TACE before this treatment. Patients with severe esophagogastric varices or refractory ascites or coagulation dysfunction before treatment.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hepatic resection<br>Indications for Hepatic resection were the presence of appropriate residual liver volume determined by volumetric computed tomography and lack of hepatic encephalopathy. | Procedure: hepatic resection<br>* The aim of this intervention is to reach curative resection.<br>* Other names: control;|
| Experimental: Transarterial Chemoembolization(TACE)<br>Transarterial Chemoembolization is performed in less than one week after clinical diagnosis. | Procedure: TACE<br>* The aim of this intervention is one of the palliative treatment.<br>* Other names: trial;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year overall survival | Overall survival rate will be evaluated at 3 years after treatment | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year overall survival | Overall survival rate will be evaluated at 1 year after treatment | 1 years | 
| 2-year overall survival | Overall survival rate will be evaluated at 2 years after treatment | 2 years | 
| Recurrence rates | any recurrence detected by CT, MRI and laboratory examination | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular Carcinoma, Hepatic Resection, TACE, Solitary Huge Tumor, Overall Survival