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

NCT ID: NCT02921139

Last Updated: 2021-08-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2022-11-30

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.

Conditions

Hepatocellular Carcinoma(HCC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

Stereotactic ablative radiotherapy (SABR)

Group Type: EXPERIMENTAL

Stereotactic ablative radiotherapy (SABR)

Intervention Type: RADIATION

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.

Arm II

Re-transcatheter arterial chemoembolization (re-TACE)

Group Type: ACTIVE_COMPARATOR

Re-Transcatheter arterial chemoembolization (re-TACE)

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: RADIATION

Re-Transcatheter arterial chemoembolization (re-TACE)

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

Intervention Type: PROCEDURE

Other Intervention Names

Stereotactic Body Radiation Therapy (SBRT); Transarterial Chemoembolization

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Buddhist Tzu Chi General Hospital

OTHER

Sponsor Role: collaborator

Hualien Tzu Chi General Hospital

OTHER

Sponsor Role: collaborator

Dalin Tzu Chi General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shih-Kai Hung, PhD

Role: PRINCIPAL_INVESTIGATOR

Chief of Department of Radiation Oncology and Cancer Center, Dalin Tzu Chi Hospital

Locations

Dalin Tzu Chi Hospital

Chiayi City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Shih-Kai Hung, PhD

Role: CONTACT

oncology158@yahoo.com.tw

+886-5-2648000 ext. 75672

Liang-Cheng Chen, MD

Role: CONTACT

atonsobek@yahoo.com.tw

+886-978609292

Facility Contacts

Liang-Cheng Chen, MD

Role: primary

atonsobek@yahoo.com.tw

+886-5-2648000 ext. 71056

References

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Reference Type: BACKGROUND

PMID: 27082566 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 24752339 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 26182200 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 26628466 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30922261 (View on PubMed)

Other Identifiers

A10502001

Identifier Type: -

Identifier Source: org_study_id