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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03191123
Other study ID # chenxp008
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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