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

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

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-05

Study Completion Date

2019-07-05

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.

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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.

Conditions

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Carcinoma, Hepatocellular Survival Rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Hepatic resection

Indications for Hepatic resection 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 PROCEDURE

The aim of this intervention is to reach curative resection.

Transarterial Chemoembolization(TACE)

Transarterial Chemoembolization is performed in less than one week after clinical diagnosis.

Group Type EXPERIMENTAL

TACE

Intervention Type PROCEDURE

The aim of this intervention is one of the palliative treatment.

Interventions

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hepatic resection

The aim of this intervention is to reach curative resection.

Intervention Type PROCEDURE

TACE

The aim of this intervention is one of the palliative treatment.

Intervention Type PROCEDURE

Other Intervention Names

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control trial

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No