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

Carcinoma, Hepatocellular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03191123
• Other study ID #: chenxp008
• Status: Recruiting
• Phase: N/A
• First received: June 14, 2017
• Last updated: April 12, 2018
• Start date: July 5, 2016
• Est. completion date: July 5, 2019

Study information

• Verified date: April 2018
• Source: Huazhong University of Science and Technology
• Contact: Ganxun Li, Doctor
• Phone: +8615271899935
• Email: liganxun[@]hust.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 5, 2019
• Est. primary completion date: July 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Survival Rate

Intervention

Procedure:
• hepatic resection
The aim of this intervention is to reach curative resection.
• TACE
The aim of this intervention is one of the palliative treatment.

Locations

Country	Name	City	State
China	Hepatic surgery center, Tong ji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

References & Publications (3)

Jin YJ, Lee JW, Choi YJ, Chung HJ, Kim YS, Lee KY, Ahn SI, Shin WY, Cho SG, Jeon YS. Surgery versus transarterial chemoembolization for solitary large hepatocellular carcinoma of BCLC stage A. J Gastrointest Surg. 2014 Mar;18(3):555-61. doi: 10.1007/s1160 — View Citation

Metussin A, Patanwala I, Cross TJ. Partial hepatectomy vs. transcatheter arterial chemoembolization for resectable multiple hepatocellular carcinoma beyond Milan criteria: a RCT. J Hepatol. 2015 Mar;62(3):747-8. doi: 10.1016/j.jhep.2014.08.057. Epub 2014 — View Citation

Yin L, Li H, Li AJ, Lau WY, Pan ZY, Lai EC, Wu MC, Zhou WP. Partial hepatectomy vs. transcatheter arterial chemoembolization for resectable multiple hepatocellular carcinoma beyond Milan Criteria: a RCT. J Hepatol. 2014 Jul;61(1):82-8. doi: 10.1016/j.jhep — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	mortality	death within 30 days after surgery	30 days
Primary	3-year overall survival	Overall survival rate will be evaluated at 3 years after treatment	3 years
Secondary	1-year overall survival	Overall survival rate will be evaluated at 1 year after treatment	1 years
Secondary	2-year overall survival	Overall survival rate will be evaluated at 2 years after treatment	2 years
Secondary	Recurrence rates	any recurrence detected by CT, MRI and laboratory examination	3 years