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

• Register: ClinicalTrials.gov
• Last refreshed on: 7 September 2021
• Main ID: NCT02921139
• Date of registration: 29/09/2016
• Prospective Registration: Yes
• Primary sponsor: Dalin Tzu Chi General Hospital
• Public title: Comparing Re-TACE Versus SABR for Post-prior-TACE Incompletely Regressed HCC: a Randomized Controlled Trial (TASABR) TASABR
• Scientific title: 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
• Date of first enrolment: November 2016
• Target sample size: 120
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02921139
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Taiwan

Contacts

• Name: Liang-Cheng Chen, MD

• Name: Shih-Kai Hung, PhD

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

Key inclusion & exclusion criteria

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



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hepatocellular Carcinoma(HCC)

Intervention(s)

Procedure: Re-Transcatheter arterial chemoembolization (re-TACE)

Radiation: Stereotactic ablative radiotherapy (SABR)

Primary Outcome(s)

freedom form local progression [Time Frame: Up to 12 months]

Secondary Outcome(s)

Response rate [Time Frame: Up to 24 months]

Duration of Response of the treated tumor [Time Frame: Up to 24 months]

Progression-free survival [Time Frame: Up to 24 months]

Overall survival [Time Frame: Up to 24 months]

Grade of toxicity [Time Frame: Up to 24 months]

Secondary ID(s)

A10502001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Buddhist Tzu Chi General Hospital

Hualien Tzu Chi General Hospital