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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02724475

Enrollment

180

Registered

2016-03-31

Start date

2012-12-31

Completion date

2015-12-31

Last updated

2016-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma, Laser Ablation, Portal Vein Tumor Thrombus

Keywords

Laser Ablation, Portal Vein Tumor, Thrombus

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.

Interventions

PROCEDURELA

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

PROCEDURE3D-CRT

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

17 Years to 70 Years

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

Design outcomes

Primary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026