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

Primary Purpose

Hepatocellular Carcinoma(HCC)

Status

Unknown status

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Stereotactic ablative radiotherapy (SABR)

Re-Transcatheter arterial chemoembolization (re-TACE)

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma(HCC) focused on measuring Hepatocellular Carcinoma, Transcatheter Arterial Chemoembolization (TACE), Stereotactic ablative radiotherapy (SABR)

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dalin Tzu Chi HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I

Arm II

Arm Description

Stereotactic ablative radiotherapy (SABR)

Re-transcatheter arterial chemoembolization (re-TACE)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Response rate

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

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

Grade of toxicity

To estimate the rate of acute and late treatment-related toxicity related to specific symptoms

Full Information

NCT ID

NCT02921139

First Posted

September 29, 2016

Last Updated

August 27, 2021

Sponsor

Dalin Tzu Chi General Hospital

Collaborators

Buddhist Tzu Chi General Hospital, Hualien Tzu Chi General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02921139

Brief Title

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

Acronym

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

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

November 2016 (undefined)

Primary Completion Date

November 2022 (Anticipated)

Study Completion Date

November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dalin Tzu Chi General Hospital

Collaborators

Buddhist Tzu Chi General Hospital, Hualien Tzu Chi General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma(HCC)

Keywords

Hepatocellular Carcinoma, Transcatheter Arterial Chemoembolization (TACE), Stereotactic ablative radiotherapy (SABR)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm I

Arm Type

Experimental

Arm Description

Stereotactic ablative radiotherapy (SABR)

Arm Title

Arm II

Arm Type

Active Comparator

Arm Description

Re-transcatheter arterial chemoembolization (re-TACE)

Intervention Type

Radiation

Intervention Name(s)

Stereotactic ablative radiotherapy (SABR)

Other Intervention Name(s)

Stereotactic Body Radiation Therapy (SBRT)

Intervention Description

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

Procedure

Intervention Name(s)

Re-Transcatheter arterial chemoembolization (re-TACE)

Other Intervention Name(s)

Transarterial Chemoembolization

Intervention Description

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

Primary Outcome Measure Information:

Title

freedom form local progression

Description

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

Time Frame

Up to 12 months

Secondary Outcome Measure Information:

Title

Overall survival

Description

To estimate the rates of overall survival. It will be estimated by Kaplan-Meier and Cox regression model adjusting for the competing risks

Time Frame

Up to 24 months

Title

Progression-free survival

Description

To estimate the rates of progression-free survival. It will be estimated by Kaplan-Meier and Cox regression model adjusting for the competing risks

Time Frame

Up to 24 months

Title

Response rate

Description

To estimate the response rate. It will be estimated by Kaplan-Meier and Cox regression model adjusting for the competing risks

Time Frame

Up to 24 months

Title

Duration of Response of the treated tumor

Description

Time Frame

Up to 24 months

Title

Grade of toxicity

Description

To estimate the rate of acute and late treatment-related toxicity related to specific symptoms

Time Frame

Up to 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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 ： 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shih-Kai Hung, PhD

Phone

+886-5-2648000

Ext

75672

oncology158@yahoo.com.tw

First Name & Middle Initial & Last Name or Official Title & Degree

Liang-Cheng Chen, MD

Phone

+886-978609292

atonsobek@yahoo.com.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shih-Kai Hung, PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dalin Tzu Chi Hospital

City

Chiayi City

ZIP/Postal Code

62247

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Liang-Cheng Chen, MD

Phone

+886-5-2648000

Ext

71056

atonsobek@yahoo.com.tw

First Name & Middle Initial & Last Name & Degree

Shih-Kai Hung, PhD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

27082566

Citation

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.

Results Reference

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PubMed Identifier

24752339

Citation

Cheng 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.

Results Reference

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PubMed Identifier

26182200

Citation

Huo 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.

Results Reference

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PubMed Identifier

22570179

Citation

Kang 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.

Results Reference

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PubMed Identifier

27062278

Citation

Takeda 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.

Results Reference

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PubMed Identifier

26628466

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.

Results Reference

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PubMed Identifier

30922261

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.

Results Reference

derived

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

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