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

N

Naval Military Medical University (Second Military Medical University)

Status

Completed

Conditions

Laser Ablation
Hepatocellular Carcinoma
Portal Vein Tumor Thrombus

Treatments

Procedure: LA
Procedure: 3D-CRT

Study type

Interventional

Funder types

Other

Identifiers

NCT02724475
2012ZX10002016003

Details and patient eligibility

About

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.

Enrollment

180 patients

Sex

All

Ages

17 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

180 participants in 2 patient groups

LA group
Experimental group
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.
Treatment:
Procedure: LA
3D-CRT group
Experimental group
Description:
γ-knife treatment with radiation dose of 48-63 Gy/6-9 times.
Treatment:
Procedure: 3D-CRT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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