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

Not Applicable

• Conditions: Hepatocellular Carcinoma(HCC)
• Interventions: Radiation: Stereotactic ablative radiotherapy (SABR); Procedure: Re-Transcatheter arterial chemoembolization (re-TACE)

• Registration Number: NCT02921139
• Lead Sponsor: Dalin Tzu Chi General Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2016-09-29
• Study First Submitted QC: 2016-09-29
• Study First Posted: 2016-10-03
• Study Start: 2016-11
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-27
• Last Update Posted: 2021-08-30
• Primary Completion: 2022-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	Stereotactic ablative radiotherapy (SABR)	Stereotactic ablative radiotherapy (SABR)
Arm II	Re-Transcatheter arterial chemoembolization (re-TACE)	Re-transcatheter arterial chemoembolization (re-TACE)

Primary Outcome Measures

Name	Time	Method
freedom form local progression	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

Secondary Outcome Measures

Name	Time	Method
Grade of toxicity	Up to 24 months	To estimate the rate of acute and late treatment-related toxicity related to specific symptoms
Overall survival	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
Progression-free survival	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
Response rate	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
Duration of Response of the treated tumor	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

Trial Locations

Locations (1)

Dalin Tzu Chi Hospital; 🇨🇳 Chiayi City, Taiwan