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

NCT03191123 | Unknown DMC

• 1 other identifier: chenxp008
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carcinoma, Hepatocellular; Survival Rate

Keywords

Hepatocellular Carcinoma; Hepatic Resection; TACE; Solitary Huge Tumor; Overall Survival

Outcome Measures

Primary Outcomes (1)

• 3-year overall survival

  Overall survival rate will be evaluated at 3 years after treatment

  3 years

Secondary Outcomes (3)

• 1-year overall survival

  1 years

• 2-year overall survival

  2 years

• Recurrence rates

  3 years

Other Outcomes (1)

• mortality

  30 days

Study Arms (2)

Hepatic resection

ACTIVE COMPARATOR

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

Transarterial Chemoembolization(TACE)

EXPERIMENTAL

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

Procedure: TACE

Interventions

hepatic resection PROCEDURE

The aim of this intervention is to reach curative resection.

Also known as: control

Hepatic resection

TACE PROCEDURE

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

Also known as: trial

Transarterial Chemoembolization(TACE)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Hepatic surgery center, Tong ji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (3)

• 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.2014.03.012. Epub 2014 Mar 17.

  PMID: 24650695 RESULT

• 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 Nov 7. No abstract available.

  PMID: 25450210 RESULT

• 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/s11605-013-2440-x. Epub 2014 Jan 14.

  PMID: 24420729 RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Clinical Trials as Topic

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Ganxun Li, Doctor

CONTACT

+8615271899935; liganxun@hust.edu.cn

Xiaoping Chen, Doctor

CONTACT

+862783665253; chenxp@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: June 19, 2017
• Study Start: July 5, 2016
• Primary Completion: July 5, 2018
• Study Completion: July 5, 2019
• Last Updated: April 13, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)