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Laser Ablation for Intermediate and Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

NCT ID: NCT02724475

Last Updated: 2016-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-12-31

Brief Summary

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Hepatocellular carcinoma (HCC) is the fifth most-common cancer worldwide and the second most-common cause of cancer mortality. Liver resection is the first-line curative treatment for huge HCC. The 5-year overall survival (OS) rates after hepatic resection were range from 25% to 45% and the incidence of portal vein tumor thrombus (PVTT) for intermediate and advanced hepatocellular carcinoma patients were as high as 60%-90%. At present, there is no effective treatment for patients with PVTT. Laser ablation (LA) showed a good performance in eliminating the PVTT and the three-dimensional conformal radiotherapy (3D-CRT) with γ Ray (γ-knife) can also be used to treat patients with PVTT. But there still lack of evidence-based research to compare the clinical outcome of 3D-CRT with γ Ray and LA. In view of this, we aim to implement a randomized controlled study to find out an effective treatment for intermediate and advanced hepatocellular carcinoma patients with PVTT based on evidence-based research.

Detailed Description

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Conditions

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Hepatocellular Carcinoma Laser Ablation Portal Vein Tumor Thrombus

Keywords

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Laser Ablation Portal Vein Tumor Thrombus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LA group

Ultrasound-guided puncture to the front of the thrombus with a power of 30 watts and pulse time of 0.3-0.4 seconds with 1 second interval until the thrombus was totally eliminated.

Group Type EXPERIMENTAL

LA

Intervention Type PROCEDURE

Ultrasound-guided puncture to the front of the thrombus with a power of 30 watts and pulse time of 0.3-0.4 seconds with 1 second interval until the thrombus was totally eliminated

3D-CRT group

γ-knife treatment with radiation dose of 48-63 Gy/6-9 times.

Group Type EXPERIMENTAL

3D-CRT

Intervention Type PROCEDURE

γ-knife treatment with radiation dose of 48-63 Gy/6-9 times

Interventions

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LA

Ultrasound-guided puncture to the front of the thrombus with a power of 30 watts and pulse time of 0.3-0.4 seconds with 1 second interval until the thrombus was totally eliminated

Intervention Type PROCEDURE

3D-CRT

γ-knife treatment with radiation dose of 48-63 Gy/6-9 times

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Child-Pugh class B liver function；
2. Preoperative ECOG criteria score of 0-2;
3. Patients preoperatively diagnosed of hepatocellular carcinoma according to chest computed tomography (CT) and/or magnetic resonance imaging (MRI);
4. Tumor thrombus in the second-order or more peripheral branch of portal vein;
5. Tumor number ≤5 and the sum of largests tumor diameter ≤15 cm;
6. The expected survival time \>6 months.

Exclusion Criteria

1. Other anticancer treatment before treatment
2. Patients with apparent major organs (i.e. cardiac, pulmonary, cerebral and renal) dysfunction, which may affect the treatment of liver cancer
3. Patients with other diseases that may affect the treatment of this treatment
4. History of other malignant tumors
5. Patients who are participating in other clinical trials
6. Pregnant, lactating women
Minimum Eligible Age

17 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role lead

Responsible Party

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ShenFeng

vice president of the Eastern Hepatobiliary Surgery Hospotal

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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2012ZX10002016003

Identifier Type: -

Identifier Source: org_study_id