Comparing Re-TACE Versus SABR for Post-prior-TACE Incompletely Regressed HCC: a Randomized Controlled Trial (TASABR)

NCT02921139 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-08-30

No results posted yet for this study

Summary

Till now, trans-arterial chemoembolization (TACE) is still one of the common modalities in treating hepatocellular carcinoma patients with unresectable intermediate stage. However, residual viable HCC after TACE is not uncommon, leading to a poor overall survival after TACE alone. Recently, stereotactic ablative radiotherapy (SABR) has been reported to be potentially useful for curatively managing early-stage HCC in retrospective studies. Thus, conducting a randomized clinical trial to test the role of SABR in eradicating post-TACE residual tumors is therefore encouraged. The present phase-III trial intended to compare clinical outcomes between TACE + SABR and TACE + re-TACE for HCC patients with post-prior-TACE residual tumors.

Conditions

  • Hepatocellular Carcinoma(HCC)

Interventions

RADIATION

Stereotactic ablative radiotherapy (SABR)

Patients with HCC after incomplete TACE are randomized to stereotactic ablative radiotherapy (SABR). SABR will be delivered in 5 fractions.The preferred inter-fraction time interval is 48 hours. The entire treatment with 10 days is preferred.

PROCEDURE

Re-Transcatheter arterial chemoembolization (re-TACE)

Patients with HCC after incomplete TACE are randomized to further re-TACE.

Sponsors & Collaborators

  • Buddhist Tzu Chi General Hospital

    collaborator OTHER
  • Hualien Tzu Chi General Hospital

    collaborator OTHER
  • Dalin Tzu Chi General Hospital

    lead OTHER

Principal Investigators

  • Shih-Kai Hung, PhD · Chief of Department of Radiation Oncology and Cancer Center, Dalin Tzu Chi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2022-11-30
Completion
2022-11-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02921139 on ClinicalTrials.gov