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Adjuvant TACE to Reduce the HCC Recurrence After Resection

Primary Purpose

Carcinoma, Hepatocellular

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Adjuvant TACE

Follow-up

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring Carcinoma,Hepatocellular, Chemoembolization, Adjuvant therapy, Hepatocellular, Microvessels invasion

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18~75 years;
Eastern Cooperative Oncology Group performance status (ECOG PS) score <=2;
Histologically confirmed hepatocellular carcinoma with microvessels invasion;
No previous treatment for HCC;
More than 5 cm solitary tumor before surgery confirmed by more than 2 radiological examinations;
R0 resection achieved;
No recurrence evidence in radiological follow-up 3~7 weeks after surgery;
Adequate hematologic parameters and liver and kidney functions: (1) Neutrophils Absolute >=1.5*10^9/L; (2) Hemoglobin >=90g/L; (3) Platelet count >=75*10^9/L; (4) Serum albumin >=35g/L; (5) Serum total bilirubin <=1.5* upper limit of normal (ULN); (6) Serum Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) <2.5*ULN; (7) Serum creatinine <=1.5*ULN; (8) International normalized ratio (INR) <=1.5;
Give signed informed consent before enrollment.

Exclusion Criteria:

Function impairment of vital organs (heart, lung, kidney, etc), serious infection or >grade 2 adverse events (Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0);
Histologically confirmed of positive resection margin (R1 resection);
Previous or current malignant tumor beyond HCC;
Allergy to any agent of the TACE regimen;
History of organ transplantation;
Previously receiving other treatments for HCC;
Pregnant or breastfeeding women, and women of childbearing potential without adequate contraception;
Neurological or mental abnormalities that may affect cognitive assessment and inform consent;
Concomitant anti-tumor therapy or participating in other interventional clinical trials;
Other psychological, family or social reason, which would affect compliance with the study protocol.

Sites / Locations

SUN YAT-SEN University Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Adjuvant TACE

Follow-up

Arm Description

Adjuvant TACE were performed 4-6 weeks after surgery

Routine follow-up were performed instead of adjuvant TACE

Outcomes

Primary Outcome Measures

Overall survival

The overall survival is defined as the percentage of patients who are alive at 5 years after their enrollments of this study.

Secondary Outcome Measures

Disease-free survival

The disease-free survival is defined as the percentage of patients who are alive at 5 years without any signs or symptoms of HCC after their enrollments of this study.

Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Full Information

NCT ID

NCT02788526

First Posted

March 23, 2016

Last Updated

June 16, 2016

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT02788526

Brief Title

Adjuvant TACE to Reduce the HCC Recurrence After Resection

Official Title

The Clinical Randomized Trial of Adjuvant Transarterial Chemo Embolization (TACE) to Reduce the Recurrence in Hepatocellular Carcinoma (HCC) Patients at High Risk After Resection

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Hepatocellular carcinoma (HCC) is the sixth most common malignancies worldwide and the second leading cause of cancer-related death. Surgical resection is still the main radical approach for HCC, but the recurrence rate after hepatectomy is very high, which hampers the further improvement of prognosis of HCC patients. The conventional risk factors of recurrence including: huge tumor, multiple lesions, vessels invasion and tumor rupture. Recently, the microvessels invasion (MVI) has been recognized a novel risk factor of recurrence after hepatectomy. The investigators' previous study showed that the recurrence rate is more than 50% for the patients with >5cm solitary tumor and MVI. The MVI was confirmed as the only independent risk factor for the overall and disease-free survival of HCC patients in multiple variables analysis. It is important to reduce the recurrence and prolong the survival of patients after hepatectomy with effective adjuvant therapy. TACE has been utilized as an adjuvant therapy after hepatectomy, but its significance is still unknown. Then, the investigators design the current prospective randomized clinical trial to evaluate the effect of adjuvant TACE to reduce the recurrence in HCC patients at high risk (>5cm solitary tumor and MVI) after resection, compared to vigilant follow-up.

Detailed Description

The patients with solitary tumor more than 5cm and microvessels invasion after radical hepatectomy were randomized to receive adjuvant TACE（1~2 cycles, 4~6 weeks) or follow-up. The main endpoint: overall survival (OS), disease-free survival(DFS), and safety were compared between this two groups.

6. Conditions and Keywords

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

Carcinoma, Hepatocellular

Keywords

Carcinoma,Hepatocellular, Chemoembolization, Adjuvant therapy, Hepatocellular, Microvessels invasion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

180 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adjuvant TACE

Arm Type

Experimental

Arm Description

Adjuvant TACE were performed 4-6 weeks after surgery

Arm Title

Follow-up

Arm Type

Other

Arm Description

Routine follow-up were performed instead of adjuvant TACE

Intervention Type

Procedure

Intervention Name(s)

Adjuvant TACE

Intervention Description

1~2 cycles TACE were performed as adjuvant therapy after radical hepatectomy

Intervention Type

Procedure

Intervention Name(s)

Follow-up

Intervention Description

Patients received just follow-up to monitor the recurrence of HCC

Primary Outcome Measure Information:

Title

Overall survival

Description

The overall survival is defined as the percentage of patients who are alive at 5 years after their enrollments of this study.

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Disease-free survival

Description

The disease-free survival is defined as the percentage of patients who are alive at 5 years without any signs or symptoms of HCC after their enrollments of this study.

Time Frame

5 years

Title

Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Description

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18~75 years; Eastern Cooperative Oncology Group performance status (ECOG PS) score <=2; Histologically confirmed hepatocellular carcinoma with microvessels invasion; No previous treatment for HCC; More than 5 cm solitary tumor before surgery confirmed by more than 2 radiological examinations; R0 resection achieved; No recurrence evidence in radiological follow-up 3~7 weeks after surgery; Adequate hematologic parameters and liver and kidney functions: (1) Neutrophils Absolute >=1.5*10^9/L; (2) Hemoglobin >=90g/L; (3) Platelet count >=75*10^9/L; (4) Serum albumin >=35g/L; (5) Serum total bilirubin <=1.5* upper limit of normal (ULN); (6) Serum Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) <2.5*ULN; (7) Serum creatinine <=1.5*ULN; (8) International normalized ratio (INR) <=1.5; Give signed informed consent before enrollment. Exclusion Criteria: Function impairment of vital organs (heart, lung, kidney, etc), serious infection or >grade 2 adverse events (Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0); Histologically confirmed of positive resection margin (R1 resection); Previous or current malignant tumor beyond HCC; Allergy to any agent of the TACE regimen; History of organ transplantation; Previously receiving other treatments for HCC; Pregnant or breastfeeding women, and women of childbearing potential without adequate contraception; Neurological or mental abnormalities that may affect cognitive assessment and inform consent; Concomitant anti-tumor therapy or participating in other interventional clinical trials; Other psychological, family or social reason, which would affect compliance with the study protocol.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rong-ping GUO, M.D.

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

SUN YAT-SEN University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

19408012

Citation

Zhong C, Guo RP, Li JQ, Shi M, Wei W, Chen MS, Zhang YQ. A randomized controlled trial of hepatectomy with adjuvant transcatheter arterial chemoembolization versus hepatectomy alone for Stage III A hepatocellular carcinoma. J Cancer Res Clin Oncol. 2009 Oct;135(10):1437-45. doi: 10.1007/s00432-009-0588-2. Epub 2009 May 1.

Results Reference

background

PubMed Identifier

7895595

Citation

Li JQ, Zhang YQ, Zhang WZ. [Evaluation of chemoembolization as an adjuvant therapy for primary liver carcinoma after surgical resection]. Zhonghua Zhong Liu Za Zhi. 1994 Sep;16(5):387-9. Chinese.

Results Reference

background

PubMed Identifier

7541051

Citation

Li JQ, Zhang YQ, Zhang WZ, Yuan YF, Li GH. Randomized study of chemoembolization as an adjuvant therapy for primary liver carcinoma after hepatectomy. J Cancer Res Clin Oncol. 1995;121(6):364-6. doi: 10.1007/BF01225689.

Results Reference

background

PubMed Identifier

16795984

Citation

Peng B, Liang L, He Q, Zhou F, Luo S. Surgical treatment for hepatocellular carcinoma with portal vein tumor thrombus. Hepatogastroenterology. 2006 May-Jun;53(69):415-9.

Results Reference

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Adjuvant TACE to Reduce the HCC Recurrence After Resection

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