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

Huazhong University of Science and Technology

Status: Unknown

Conditions: Carcinoma, Hepatocellular; Survival Rate

Treatments: Procedure: hepatic resection; Procedure: TACE

Study type: Interventional

Funder types: Other

Identifiers

NCT03191123

chenxp008

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Hepatic resection

Active Comparator group

Description:

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

Treatment:

Procedure: hepatic resection

Transarterial Chemoembolization(TACE)

Experimental group

Description:

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

Treatment:

Procedure: TACE