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

Primary Purpose

Carcinoma, Hepatocellular, Survival Rate

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

hepatic resection

TACE

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring Hepatocellular Carcinoma, Hepatic Resection, TACE, Solitary Huge Tumor, Overall Survival

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Hepatic surgery center, Tong ji HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Hepatic resection

Transarterial Chemoembolization(TACE)

Arm Description

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

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

Outcomes

Primary Outcome Measures

3-year overall survival

Overall survival rate will be evaluated at 3 years after treatment

Secondary Outcome Measures

1-year overall survival

Overall survival rate will be evaluated at 1 year after treatment

2-year overall survival

Overall survival rate will be evaluated at 2 years after treatment

Recurrence rates

any recurrence detected by CT, MRI and laboratory examination

Full Information

NCT ID

NCT03191123

First Posted

June 14, 2017

Last Updated

April 12, 2018

Sponsor

Huazhong University of Science and Technology

1. Study Identification

Unique Protocol Identification Number

NCT03191123

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Unknown status

Study Start Date

July 5, 2016 (Actual)

Primary Completion Date

July 5, 2018 (Anticipated)

Study Completion Date

July 5, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Huazhong University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Hepatocellular, Survival Rate

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hepatic resection

Arm Type

Active Comparator

Arm Description

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

Arm Title

Transarterial Chemoembolization(TACE)

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

hepatic resection

Other Intervention Name(s)

control

Intervention Description

The aim of this intervention is to reach curative resection.

Intervention Type

Procedure

Intervention Name(s)

TACE

Other Intervention Name(s)

trial

Intervention Description

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

Primary Outcome Measure Information:

Title

3-year overall survival

Description

Overall survival rate will be evaluated at 3 years after treatment

Time Frame

3 years

Secondary Outcome Measure Information:

Title

1-year overall survival

Description

Overall survival rate will be evaluated at 1 year after treatment

Time Frame

1 years

Title

2-year overall survival

Description

Overall survival rate will be evaluated at 2 years after treatment

Time Frame

2 years

Title

Recurrence rates

Description

any recurrence detected by CT, MRI and laboratory examination

Time Frame

3 years

Other Pre-specified Outcome Measures:

Title

mortality

Description

death within 30 days after surgery

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ganxun Li, Doctor

Phone

+8615271899935

liganxun@hust.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaoping Chen, Doctor

Phone

+862783665253

chenxp@medmail.com.cn

Facility Information:

Facility Name

Hepatic surgery center, Tong ji Hospital

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430030

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaoping Chen, Doctor

Phone

8602783662851

chenxp@medmail.com.cn

First Name & Middle Initial & Last Name & Degree

Ganxun Li, Doctor

Phone

8615271899935

liganxun@hust.edu.cn

First Name & Middle Initial & Last Name & Degree

peng zhu, doctor

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24650695

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.2014.03.012. Epub 2014 Mar 17.

Results Reference

result

PubMed Identifier

25450210

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 Nov 7. No abstract available.

Results Reference

result

PubMed Identifier

24420729

Citation

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.

Results Reference

result

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

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