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Combination Treatment for Advanced Liver Cancer

Primary Purpose

Hepatocellular Carcinoma, Hepatic Portal Vein Tumor Invasion

Status

Withdrawn

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

chemoembolization

endovascular stents implantation

iodine-125 seed strand implantation

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, portal vein tumor thrombosis, stents, chemoembolization

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

(1) Hepatocellular carcinoma(HCC) diagnosis confirmed by needle biopsy or by two coincidental imaging techniques associated with increased α-fetoprotein according to the American Association for the Study of Liver Diseases (AASLD) guidelines and contrast-enhancing tumour thrombus within the main portal vein and one of the first-order branch on CT or MRI;
(2) Child-Pugh classification grade A or B；
（3）Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.

Exclusion Criteria:

advanced liver disease (bilirubin levels >3 mg/dL, ASTor ALT >5 × upper limit of normal)；
Tumor invade the Inferior Vena Cava, extrahepatic spread;
contraindications for doxorubicin or oxaliplatin chemotherapy;
any contraindication to an arterial procedure such as impaired clotting tests (platelet count below 50 × 109/L or prothrombin activity below 50 %);
renal failure,cardiac ejection fraction <50 %) or end-stage disease；
patients who were not capable of cooperation during the procedure.

Sites / Locations

Department of Interventional Radiology, Zhongshan Hospital, Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TACE&Stents

TACE

Arm Description

chemoembolization combined with endovascular stents and iodine-125 seed strand implantation

Transartery chemoembolisation（TACE） by administering Doxorubicin and Oxaliplatin mixed with 5-20 mL iodised oil.Gelatine sponge was used to embolise the feeding artery of the tumour.Repeat if patients with viable lesions demonstrated by CT or MRI.

Outcomes

Primary Outcome Measures

Median survival time

Secondary Outcome Measures

Time to Disease Progression

Full Information

NCT ID

NCT02149771

First Posted

May 25, 2014

Last Updated

April 17, 2018

Sponsor

Shanghai Zhongshan Hospital

Collaborators

Shanghai Municipal Science and Technology Commission

1. Study Identification

Unique Protocol Identification Number

NCT02149771

Brief Title

Combination Treatment for Advanced Liver Cancer

Official Title

Transarterial Chemoembolisation (TACE) Combined With Endovascular Implantation of Bare Stent and Iodine-125 Seed Strand for the Treatment of Hepatocellular Carcinoma With Portal Vein Tumour Thrombosis Versus TACE Alone

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Insufficient funding

Study Start Date

May 2014 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Zhongshan Hospital

Collaborators

Shanghai Municipal Science and Technology Commission

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine whether TACE combined endovascular stent implantation confers a survival benefit over TACE alone.

6. Conditions and Keywords

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

Hepatocellular Carcinoma, Hepatic Portal Vein Tumor Invasion

Keywords

hepatocellular carcinoma, portal vein tumor thrombosis, stents, chemoembolization

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TACE&Stents

Arm Type

Experimental

Arm Description

chemoembolization combined with endovascular stents and iodine-125 seed strand implantation

Arm Title

TACE

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

chemoembolization

Intervention Description

Conventional chemoembolisation by administering Doxorubicin and Oxaliplatin mix with 5-20 mL iodised oil.Gelatine sponge was used to embolise the feeding artery of the tumour.Repeat if patients with viable lesions demonstrated by CT or MRI.

Intervention Type

Device

Intervention Name(s)

endovascular stents implantation

Intervention Description

Bare stents implant within portal vein.

Intervention Type

Procedure

Intervention Name(s)

iodine-125 seed strand implantation

Intervention Description

Iodine-125 seed strand implant within portal vein.

Primary Outcome Measure Information:

Title

Median survival time

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Time to Disease Progression

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: (1) Hepatocellular carcinoma(HCC) diagnosis confirmed by needle biopsy or by two coincidental imaging techniques associated with increased α-fetoprotein according to the American Association for the Study of Liver Diseases (AASLD) guidelines and contrast-enhancing tumour thrombus within the main portal vein and one of the first-order branch on CT or MRI; (2) Child-Pugh classification grade A or B；（3）Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less. Exclusion Criteria: advanced liver disease (bilirubin levels >3 mg/dL, ASTor ALT >5 × upper limit of normal)； Tumor invade the Inferior Vena Cava, extrahepatic spread; contraindications for doxorubicin or oxaliplatin chemotherapy; any contraindication to an arterial procedure such as impaired clotting tests (platelet count below 50 × 109/L or prothrombin activity below 50 %); renal failure,cardiac ejection fraction <50 %) or end-stage disease； patients who were not capable of cooperation during the procedure.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhinping Yan, MD

Organizational Affiliation

Department of Interventional Radiology, Zhongshan Hospital, Fudan University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jianjun Luo, MD

Organizational Affiliation

Department of Interventional Radiology, Zhongshan Hospital, Fudan University

Official's Role

Study Director

Facility Information:

Facility Name

Department of Interventional Radiology, Zhongshan Hospital, Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

12. IPD Sharing Statement

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Combination Treatment for Advanced Liver Cancer

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