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

Study Overview
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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.

Official Title
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Laser Ablation for Intermediate and Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: A Randomized Controlled Trial

Conditions
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Hepatocellular Carcinoma, Laser Ablation, Portal Vein Tumor Thrombus

Intervention / Treatment
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* Procedure: LA
* Procedure: 3D-CRT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LA group<br>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. | Procedure: LA<br>* 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<br>|
| Experimental: 3D-CRT group<br>γ-knife treatment with radiation dose of 48-63 Gy/6-9 times. | Procedure: 3D-CRT<br>* γ-knife treatment with radiation dose of 48-63 Gy/6-9 times<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxic and side effects caused by 3D-CRT or LA |  | 3 years | 
| Postoperative complication |  | 3 years | 
| Overall survival |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laser Ablation, Portal Vein Tumor, Thrombus