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

August 27, 2021 updated by: Dalin Tzu Chi General Hospital

Comparing Re-trans-catheter Arterial Chemoembolization Versus Stereotactic Ablative Radiotherapy for Hepatocellular Carcinoma Patients Who Had Incomplete Response After Prior TACE (TASABR Trial): a Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Developing effective treatment modalities is crucial in managing HCC patients with unresectable intermediate stage. Nowadays, many therapies have been used for treating this group of HCC patients, including TACE. However, residual tumors after TACE are not uncommon. In conventional, re-TACE is recommended for managing residual tumors. However, accumulated overall survival is still poor in consecutive TACEs, leading to a low rate of <20% in 5 years.

In this regard, radiotherapy has been proved to be effective in managing HCC patients, especially a novel technique named SABR. When compared with conventional-fractionated radiotherapy, SABR demonstrated better treatment responses with fewer side effects in managing primary or metastatic liver tumors. In the literature, phase I and II trials of TACE plus SABR showed excellent local control rates and promising 1- and 2-year survival rates. However, till now, there is no head-to-head comparison between TACE + SABR and consecutive TACEs.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Chiayi City, Taiwan, 62247
        • Recruiting
        • Dalin Tzu Chi Hospital
        • Contact:
        • Principal Investigator:
          • Shih-Kai Hung, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient has a) Radiographic enhancing liver lesions with early enhance and delay wash out on triple phase CT or MRI or b) histological confirmation of HCC as determined by the Liver Tumor Board
  • Age ≧ 20
  • Genders: Both male and female
  • Barcelona Clinic Liver Cancer (BCLC) stage A to B
  • Child-Pugh A or B
  • Unresectable tumors or medically inoperable status or surgery was declined/refused.
  • Meets clinical criteria for eligibility for TACE or SABR
  • SABR can be applied within 6 weeks of registration
  • Eastern Cooperative Oncology Group (ECOG) 0 or 1
  • Life expectancy > 12 weeks
  • negative pregnancy
  • No prior treatment, except for surgical resection and radiofrequency ablation (RFA)

  • Lab ：

    1. Hemoglobin ≧ 8.0 g/dL(may be post-transfusion if clinically indicated)
    2. Total bilirubin ≦ 3.0 mg/dL
    3. Aspartate aminotransferase (AST) ≦ 5x institutional upper limit of normal
    4. Alanine transaminase (ALT) ≦ 5x institutional upper limit of normal
    5. Absolute neutrophil count ≧ 1,000 /μl
    6. Platelet count ≧ 20,000/μl (may be post-transfusion if clinically indicated)
    7. Prothrombin time-international normalized ratio ≤ 1.7

Exclusion Criteria:

  • Previous TACE ≥ 2 times
  • Prior radiotherapy to the upper abdomen
  • Prior invasive malignancy other than primary liver malignancy (except non-melanomatous skin cancer) unless disease free for at least 3 years
  • metastatic disease
  • cardiac ischemia or stroke within last 6 months
  • medical or psychosocial condition unsuitable
  • History of sorafenib therapy within 21 days prior

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
Stereotactic ablative radiotherapy (SABR)
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.
Other Names:
  • Stereotactic Body Radiation Therapy (SBRT)
Active Comparator: Arm II
Re-transcatheter arterial chemoembolization (re-TACE)
Procedure: Re-Transcatheter arterial chemoembolization (re-TACE)
Patients with HCC after incomplete TACE are randomized to further re-TACE.
Other Names:
  • Transarterial Chemoembolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
freedom form local progression
Time Frame: Up to 12 months
The freedom from local progression is defined as no in-field progressive disease. It will be estimated by Kaplan-Meier and Cox regression model adjusting for the competing risks
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Up to 24 months
To estimate the rates of overall survival. It will be estimated by Kaplan-Meier and Cox regression model adjusting for the competing risks
Up to 24 months
Progression-free survival
Time Frame: Up to 24 months
To estimate the rates of progression-free survival. It will be estimated by Kaplan-Meier and Cox regression model adjusting for the competing risks
Up to 24 months
Response rate
Time Frame: Up to 24 months
To estimate the response rate. It will be estimated by Kaplan-Meier and Cox regression model adjusting for the competing risks
Up to 24 months
Duration of Response of the treated tumor
Time Frame: Up to 24 months
The duration of the response is from the time response is achieved until disease progression is detected. It will be estimated by Kaplan-Meier and Cox regression model adjusting for the competing risks
Up to 24 months
Grade of toxicity
Time Frame: Up to 24 months
To estimate the rate of acute and late treatment-related toxicity related to specific symptoms
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dalin Tzu Chi General Hospital

Collaborators

Buddhist Tzu Chi General Hospital
Hualien Tzu Chi General Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

September 29, 2016

First Submitted That Met QC Criteria

September 29, 2016

First Posted (Estimate)

October 3, 2016

Study Record Updates

Last Update Posted (Actual)

August 30, 2021

Last Update Submitted That Met QC Criteria

August 27, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A10502001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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