Hepatocellular Carcinoma(HCC)TASABRNCT02921139
Comparing Re-TACE Versus SABR for Post-prior-TACE Incompletely Regressed HCC: a Randomized Controlled Trial (TASABR)
A study testing Stereotactic ablative radiotherapy (SABR) and Re-Transcatheter arterial chemoembolization (re-TACE) in people with Hepatocellular Carcinoma(HCC), run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatocellular Carcinoma(HCC)
- What is being tested?
- Stereotactic ablative radiotherapy (SABR) and Re-Transcatheter arterial chemoembolization (re-TACE)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2016to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 20Show fewer
- 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 ：
- Hemoglobin ≧ 8.0 g/dL(may be post-transfusion if clinically indicated)
- Total bilirubin ≦ 3.0 mg/dL
- Aspartate aminotransferase (AST) ≦ 5x institutional upper limit of normal
- Alanine transaminase (ALT) ≦ 5x institutional upper limit of normal
- Absolute neutrophil count ≧ 1,000 /μl
- Platelet count ≧ 20,000/μl (may be post-transfusion if clinically indicated)
- Prothrombin time-international normalized ratio ≤ 1.7
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Dalin Tzu Chi Hospital
Chiayi City, 62247
Liang-Cheng Chen, MD, +886-5-2648000 ext. 71056, atonsobek@yahoo.com.tw
Shih-Kai Hung, PhD
About this study
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
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.
Read the 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)
- Being tested
- Stereotactic ablative radiotherapy (SABR), Re-Transcatheter arterial chemoembolization (re-TACE)
- Keywords
- Hepatocellular Carcinoma, Transcatheter Arterial Chemoembolization (TACE), Stereotactic ablative radiotherapy (SABR)
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic ablative radiotherapy (SABR)Radiation
Also called Stereotactic Body Radiation Therapy (SBRT)
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.
Re-Transcatheter arterial chemoembolization (re-TACE)Procedure or surgery
Also called Transarterial Chemoembolization
Patients with HCC after incomplete TACE are randomized to further re-TACE.
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Stereotactic ablative radiotherapy (SABR) Receives: Radiation: Stereotactic ablative radiotherapy (SABR) |
| Arm II | Active comparator | Re-transcatheter arterial chemoembolization (re-TACE) Receives: Procedure: Re-Transcatheter arterial chemoembolization (re-TACE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
freedom form local progression
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
Measured: Up to 12 months
Secondary outcomes (5)
Overall survival
To estimate the rates of overall survival. It will be estimated by Kaplan-Meier and Cox regression model adjusting for the competing risks
Measured: Up to 24 months
Progression-free survival
To estimate the rates of progression-free survival. It will be estimated by Kaplan-Meier and Cox regression model adjusting for the competing risks
Measured: Up to 24 months
Response rate
To estimate the response rate. It will be estimated by Kaplan-Meier and Cox regression model adjusting for the competing risks
Measured: Up to 24 months
Duration of Response of the treated tumor
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
Measured: Up to 24 months
Grade of toxicity
To estimate the rate of acute and late treatment-related toxicity related to specific symptoms
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma(HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalin Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Buddhist Tzu Chi General Hospital, Hualien Tzu Chi General Hospital
- Responsible party
- Sponsor
- Investigators
- Shih-Kai Hung, PhD, Principal investigator, Chief of Department of Radiation Oncology and Cancer Center, Dalin Tzu Chi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921139
- Sponsor's protocol ID
- A10502001
- Acronym
- TASABR
- Status last verified
- Aug 2021
- First submitted
- 29 Sep 2016
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Chang IC, Huang SF, Chen PJ, Chen CL, Chen CL, Wu CC, Tsai CC, Lee PH, Chen MF, Lee CM, Yu HC, Lo GH, Yeh CT, Hong CC, Eng HL, Wang J, Tseng HH, Hsiao CH, Wu HI, Yen TC, Liaw YF. The Hepatitis Viral Status in Patients With Hepatocellular Carcinoma: a Study of 3843 Patients From Taiwan Liver Cancer Network. Medicine (Baltimore). 2016 Apr;95(15):e3284. doi: 10.1097/MD.0000000000003284.
PubMed 27082566Cheng X, Sun P, Hu QG, Song ZF, Xiong J, Zheng QC. Transarterial (chemo)embolization for curative resection of hepatocellular carcinoma: a systematic review and meta-analyses. J Cancer Res Clin Oncol. 2014 Jul;140(7):1159-70. doi: 10.1007/s00432-014-1677-4. Epub 2014 Apr 22.
PubMed 24752339Huo YR, Eslick GD. Transcatheter Arterial Chemoembolization Plus Radiotherapy Compared With Chemoembolization Alone for Hepatocellular Carcinoma: A Systematic Review and Meta-analysis. JAMA Oncol. 2015 Sep;1(6):756-65. doi: 10.1001/jamaoncol.2015.2189.
PubMed 26182200Kang JK, Kim MS, Cho CK, Yang KM, Yoo HJ, Kim JH, Bae SH, Jung DH, Kim KB, Lee DH, Han CJ, Kim J, Park SC, Kim YH. Stereotactic body radiation therapy for inoperable hepatocellular carcinoma as a local salvage treatment after incomplete transarterial chemoembolization. Cancer. 2012 Nov 1;118(21):5424-31. doi: 10.1002/cncr.27533. Epub 2012 May 8.
PubMed 22570179Takeda A, Sanuki N, Tsurugai Y, Iwabuchi S, Matsunaga K, Ebinuma H, Imajo K, Aoki Y, Saito H, Kunieda E. Phase 2 study of stereotactic body radiotherapy and optional transarterial chemoembolization for solitary hepatocellular carcinoma not amenable to resection and radiofrequency ablation. Cancer. 2016 Jul 1;122(13):2041-9. doi: 10.1002/cncr.30008. Epub 2016 Apr 8.
PubMed 27062278Wahl 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.
PubMed 26628466Chen 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.
PubMed 30922261
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02921139
- Acronym / sponsor ID
- TASABR / A10502001
- Conditions
- Hepatocellular Carcinoma(HCC)
- Keywords
- Hepatocellular Carcinoma, Transcatheter Arterial Chemoembolization (TACE), Stereotactic ablative radiotherapy (SABR)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Dalin Tzu Chi General HospitalUniversity, hospital or other
- Collaborators
- Buddhist Tzu Chi General Hospital, Hualien Tzu Chi General Hospital
- Study start
- Nov 2016
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 3 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Radiation: Stereotactic ablative radiotherapy (SABR)Stereotactic ablative radiotherapy (SABR) |
| Arm II | Active comparator | Procedure: Re-Transcatheter arterial chemoembolization (re-TACE)Re-transcatheter arterial chemoembolization (re-TACE) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic ablative radiotherapy (SABR)Also: Stereotactic Body Radiation Therapy (SBRT)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. | Radiation | Arm I |
| Re-Transcatheter arterial chemoembolization (re-TACE)Also: Transarterial ChemoembolizationPatients with HCC after incomplete TACE are randomized to further re-TACE. | Procedure or surgery | Arm II |
Primary outcome
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
5 secondary outcomes
Overall survival
Time frame: Up to 24 months
Progression-free survival
Time frame: Up to 24 months
Response rate
Time frame: Up to 24 months
Duration of Response of the treated tumor
Time frame: Up to 24 months
Grade of toxicity
Time frame: Up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Background: PubMed 27082566Chang IC, Huang SF, Chen PJ, Chen CL, Chen CL, Wu CC, Tsai CC, Lee PH, Chen MF, Lee CM, Yu HC, Lo GH, Yeh CT, Hong CC, Eng HL, Wang J, Tseng HH, Hsiao CH, Wu HI, Yen TC, Liaw YF. The Hepatitis Viral Status in Patients With Hepatocellular Carcinoma: a Study of 3843 Patients From Taiwan Liver Cancer Network. Medicine (Baltimore). 2016 Apr;95(15):e3284. doi: 10.1097/MD.0000000000003284.
- Background: PubMed 24752339Cheng X, Sun P, Hu QG, Song ZF, Xiong J, Zheng QC. Transarterial (chemo)embolization for curative resection of hepatocellular carcinoma: a systematic review and meta-analyses. J Cancer Res Clin Oncol. 2014 Jul;140(7):1159-70. doi: 10.1007/s00432-014-1677-4. Epub 2014 Apr 22.
- Background: PubMed 26182200Huo YR, Eslick GD. Transcatheter Arterial Chemoembolization Plus Radiotherapy Compared With Chemoembolization Alone for Hepatocellular Carcinoma: A Systematic Review and Meta-analysis. JAMA Oncol. 2015 Sep;1(6):756-65. doi: 10.1001/jamaoncol.2015.2189.
- Background: PubMed 22570179Kang JK, Kim MS, Cho CK, Yang KM, Yoo HJ, Kim JH, Bae SH, Jung DH, Kim KB, Lee DH, Han CJ, Kim J, Park SC, Kim YH. Stereotactic body radiation therapy for inoperable hepatocellular carcinoma as a local salvage treatment after incomplete transarterial chemoembolization. Cancer. 2012 Nov 1;118(21):5424-31. doi: 10.1002/cncr.27533. Epub 2012 May 8.
- Background: PubMed 27062278Takeda A, Sanuki N, Tsurugai Y, Iwabuchi S, Matsunaga K, Ebinuma H, Imajo K, Aoki Y, Saito H, Kunieda E. Phase 2 study of stereotactic body radiotherapy and optional transarterial chemoembolization for solitary hepatocellular carcinoma not amenable to resection and radiofrequency ablation. Cancer. 2016 Jul 1;122(13):2041-9. doi: 10.1002/cncr.30008. Epub 2016 Apr 8.
- Background: PubMed 26628466Wahl 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.
- Derived from this study: PubMed 30922261Chen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shih-Kai Hung, PhD principal investigator
Chief of Department of Radiation Oncology and Cancer Center, Dalin Tzu Chi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic ablative radiotherapy (SABR) and Re-Transcatheter arterial chemoembolization (re-TACE) in people with Hepatocellular Carcinoma(HCC), run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shih-Kai Hung, PhD (+886-5-2648000 ext. 75672, oncology158@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
freedom form local progression (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02921139, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021.