Clinical trial NCT02921139: Comparing Re-TACE Versus SABR for Post-prior-TACE Incompletely Regressed HCC: a Randomized Controlled Trial (TASABR)
Official 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma(HCC)
Keywords: Hepatocellular Carcinoma
Transcatheter Arterial Chemoembolization (TACE)
Stereotactic ablative radiotherapy (SABR)
Lead sponsor: Dalin Tzu Chi General Hospital
Sponsor class: OTHER
Collaborators: name: Buddhist Tzu Chi General Hospital
name: Hualien Tzu Chi General Hospital
First posted: 2016-10-03
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: freedom form local progression
timeFrame: Up to 12 months
Secondary outcomes:
measure: Overall survival
timeFrame: Up to 24 months
measure: Progression-free survival
timeFrame: Up to 24 months
measure: Response rate
timeFrame: Up to 24 months
measure: Duration of Response of the treated tumor
timeFrame: Up to 24 months
measure: Grade of toxicity
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Chiayi City
country: Taiwan
facility: Dalin Tzu Chi Hospital
Study officials:
affiliation: Chief of Department of Radiation Oncology and Cancer Center, Dalin Tzu Chi Hospital
name: Shih-Kai Hung, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Wahl DR, Stenmark MH, Tao Y, Pollom EL, Caoili EM, Lawrence TS, Schipper MJ, Feng M. Outcomes After Stereotactic Body Radiotherapy or Radiofrequency Ablation for Hepatocellular Carcinoma. J Clin Oncol. 2016 Feb 10;34(5):452-9. doi: 10.1200/JCO.2015.61.4925. Epub 2015 Nov 30.
citation: Chen LC, Chiou WY, Lin HY, Lee MS, Lo YC, Huang LW, Chang CM, Hung TH, Lin CW, Tseng KC, Liu DW, Hsu FC, Hung SK. Comparing stereotactic ablative radiotherapy (SABR) versus re-trans-catheter arterial chemoembolization (re-TACE) for hepatocellular carcinoma patients who had incomplete response after initial TACE (TASABR): a randomized controlled trial. BMC Cancer. 2019 Mar 28;19(1):275. doi: 10.1186/s12885-019-5461-3.