NCT02724475

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed
Last Updated

March 31, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

March 28, 2016

Last Update Submit

March 28, 2016

Conditions

Hepatocellular CarcinomaLaser AblationPortal Vein Tumor Thrombus

Keywords

Laser AblationPortal Vein TumorThrombus

Outcome Measures

Primary Outcomes (3)

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

    3 years

  • Postoperative complication

    3 years

  • Overall survival

    3 years

Study Arms (2)

LA group

EXPERIMENTAL

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

3D-CRT group

EXPERIMENTAL

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

Procedure: 3D-CRT

Interventions

LAPROCEDURE

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

LA group
3D-CRTPROCEDURE

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

3D-CRT group

Eligibility Criteria

Age17 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, 200438, China

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularThrombosis

Interventions

Radiotherapy, Conformal

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice president of the Eastern Hepatobiliary Surgery Hospotal

Study Record Dates

First Submitted

March 28, 2016

First Posted

March 31, 2016

Study Start

December 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2015

Last Updated

March 31, 2016

Record last verified: 2016-03

Locations

CN(1)