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Different Protocols for Repeated Transarterial Chemoembolization in the Treatment of Patients With Hepatocellular Carcinoma

Primary Purpose

Liver Cancer

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

transarterial chemoembolization

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring Hepatocellular carcinoma, Transarterial chemoembolization, Gemcitabine

Eligibility Criteria

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

Inclusion Criteria:

Patients with histologically confirmed HCC with unresectable disease without extrahepatic metastases;
HCC with no previous treatment;
age between 18 and 75 years;
Life expectancy of at least 8 weeks;
main tumor size greater than 5 cm;
adequate hematologic function (platelet count: >60 × 109 platelets/L; hemoglobin: >90g/L; and prothrombin time: <3 seconds above control);
adequate renal function (serum creatinine: ≤1.5 × upper limit of normal);
Child-Pugh classification A or B grade;
Barcelona Clinic Liver Cancer (BCLC) stage B or C;
Eastern Co-operative Group performance status of zero or one.

Exclusion Criteria:

a hypovascular tumor (defined as a tumor with all its parts less contrast-enhanced than the nontumorous liver parenchyma on arterial phase computed tomography scans);
diffuse-type HCC;
evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy;
severe underlying cardiac or renal diseases;
color Doppler ultrasonography showing portal vein tumor thrombosis with complete main portal vein obstruction without cavernous transformation; or obstructive jaundice.

Sites / Locations

Department of Interventional Radiology; Cancer Center; Guangdong General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

Group 1 received single-drug (doxorubicin)transarterial chemoembolization.

Group 2 received double-drug (doxorubicin and mitomycin C)transarterial chemoembolization

Group 3 were treated with triple-drug (doxorubicin, mitomycin C and gemcitabine)transarterial chemoembolization.

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

Full Information

NCT ID

NCT02038296

First Posted

January 15, 2014

Last Updated

January 16, 2014

Sponsor

Guangdong Provincial People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02038296

Brief Title

Different Protocols for Repeated Transarterial Chemoembolization in the Treatment of Patients With Hepatocellular Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Guangdong Provincial People's Hospital

4. Oversight

5. Study Description

Brief Summary

To evaluate local tumor control and survival rate after repeated transarterial chemoembolization(TACE) using three different protocols in hepatocellular carcinoma (HCC) patients.

6. Conditions and Keywords

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

Liver Cancer

Keywords

Hepatocellular carcinoma, Transarterial chemoembolization, Gemcitabine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Factorial Assignment

Masking

Participant

Allocation

Randomized

Enrollment

162 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Group 1 received single-drug (doxorubicin)transarterial chemoembolization.

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Group 2 received double-drug (doxorubicin and mitomycin C)transarterial chemoembolization

Arm Title

Group 3

Arm Type

Experimental

Arm Description

Group 3 were treated with triple-drug (doxorubicin, mitomycin C and gemcitabine)transarterial chemoembolization.

Intervention Type

Procedure

Intervention Name(s)

transarterial chemoembolization

Primary Outcome Measure Information:

Title

overall survival

Time Frame

1-2 year

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: Patients with histologically confirmed HCC with unresectable disease without extrahepatic metastases; HCC with no previous treatment; age between 18 and 75 years; Life expectancy of at least 8 weeks; main tumor size greater than 5 cm; adequate hematologic function (platelet count: >60 × 109 platelets/L; hemoglobin: >90g/L; and prothrombin time: <3 seconds above control); adequate renal function (serum creatinine: ≤1.5 × upper limit of normal); Child-Pugh classification A or B grade; Barcelona Clinic Liver Cancer (BCLC) stage B or C; Eastern Co-operative Group performance status of zero or one. Exclusion Criteria: a hypovascular tumor (defined as a tumor with all its parts less contrast-enhanced than the nontumorous liver parenchyma on arterial phase computed tomography scans); diffuse-type HCC; evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy; severe underlying cardiac or renal diseases; color Doppler ultrasonography showing portal vein tumor thrombosis with complete main portal vein obstruction without cavernous transformation; or obstructive jaundice.

Facility Information:

Facility Name

Department of Interventional Radiology; Cancer Center; Guangdong General Hospital

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

12. IPD Sharing Statement

Learn more about this trial

Different Protocols for Repeated Transarterial Chemoembolization in the Treatment of Patients With Hepatocellular Carcinoma

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