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

Primary Purpose

Hepatocellular Carcinoma, Laser Ablation, Portal Vein Tumor Thrombus

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
LA
3D-CRT
Sponsored by
Eastern Hepatobiliary Surgery Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Laser Ablation, Portal Vein Tumor, Thrombus

Eligibility Criteria

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

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

Sites / Locations

  • Eastern hepatobilliary surgery hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

LA group

3D-CRT group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Toxic and side effects caused by 3D-CRT or LA
Postoperative complication
Overall survival

Secondary Outcome Measures

Full Information

First Posted
March 28, 2016
Last Updated
March 28, 2016
Sponsor
Eastern Hepatobiliary Surgery Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02724475
Brief Title
Laser Ablation for Intermediate and Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombus
Official Title
Laser Ablation for Intermediate and Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Hepatobiliary Surgery Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Laser Ablation, Portal Vein Tumor Thrombus
Keywords
Laser Ablation, Portal Vein Tumor, Thrombus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LA group
Arm Type
Experimental
Arm Description
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.
Arm Title
3D-CRT group
Arm Type
Experimental
Arm Description
γ-knife treatment with radiation dose of 48-63 Gy/6-9 times.
Intervention Type
Procedure
Intervention Name(s)
LA
Intervention Description
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
Intervention Name(s)
3D-CRT
Intervention Description
γ-knife treatment with radiation dose of 48-63 Gy/6-9 times
Primary Outcome Measure Information:
Title
Toxic and side effects caused by 3D-CRT or LA
Time Frame
3 years
Title
Postoperative complication
Time Frame
3 years
Title
Overall survival
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Child-Pugh class B liver function； Preoperative ECOG criteria score of 0-2; Patients preoperatively diagnosed of hepatocellular carcinoma according to chest computed tomography (CT) and/or magnetic resonance imaging (MRI); Tumor thrombus in the second-order or more peripheral branch of portal vein; Tumor number ≤5 and the sum of largests tumor diameter ≤15 cm; The expected survival time >6 months. Exclusion Criteria: Other anticancer treatment before treatment Patients with apparent major organs (i.e. cardiac, pulmonary, cerebral and renal) dysfunction, which may affect the treatment of liver cancer Patients with other diseases that may affect the treatment of this treatment History of other malignant tumors Patients who are participating in other clinical trials Pregnant, lactating women
Facility Information:
Facility Name
Eastern hepatobilliary surgery hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200438
Country
China

12. IPD Sharing Statement

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

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