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NCT Number: NCT02724475

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

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Cardiovascular Diseases Digestive System Diseases Digestive System Neoplasms Embolism and Thrombosis Laser Ablation Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Portal Vein Tumor Thrombus Thrombosis Vascular Diseases

Age range

17 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, 200438, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LA

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

Procedure

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

Primary outcomes

  1. Toxic and side effects caused by 3D-CRT or LA

    Time frame: 3 years

  2. Postoperative complication

    Time frame: 3 years

  3. Overall survival

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Eastern Hepatobiliary Surgery Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Mar 31, 2016
Registry last updated
Mar 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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