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

NCT02921139 | Unknown DMC

• 1 other identifier: A10502001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma(HCC)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 12 months

Secondary Outcomes (5)

• Overall survival

  Up to 24 months

• Progression-free survival

  Up to 24 months

• Response rate

  Up to 24 months

• Duration of Response of the treated tumor

  Up to 24 months

• Grade of toxicity

  Up to 24 months

Study Arms (2)

Arm I

EXPERIMENTAL

Stereotactic ablative radiotherapy (SABR)

Radiation: Stereotactic ablative radiotherapy (SABR)

Arm II

ACTIVE COMPARATOR

Re-transcatheter arterial chemoembolization (re-TACE)

Procedure: Re-Transcatheter arterial chemoembolization (re-TACE)

Interventions

Stereotactic ablative radiotherapy (SABR) 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.

Also known as: Stereotactic Body Radiation Therapy (SBRT)

Arm I

Re-Transcatheter arterial chemoembolization (re-TACE) PROCEDURE

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

Also known as: Transarterial Chemoembolization

Arm II

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dalin Tzu Chi General Hospital: lead
• Buddhist Tzu Chi General Hospital: collaborator
• Hualien Tzu Chi General Hospital: collaborator

Study Sites (1)

Dalin Tzu Chi Hospital

Chiayi City, 62247, Taiwan

RECRUITING

Related Publications (7)

• 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.

  PMID: 27082566 BACKGROUND

• 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.

  PMID: 24752339 BACKGROUND

• 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.

  PMID: 26182200 BACKGROUND

• 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.

  PMID: 22570179 BACKGROUND

• 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.

  PMID: 27062278 BACKGROUND

• 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.

  PMID: 26628466 BACKGROUND

• 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.

  PMID: 30922261 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Shih-Kai Hung, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shih-Kai Hung, PhD

CONTACT

+886-5-2648000; oncology158@yahoo.com.tw

Liang-Cheng Chen, MD

CONTACT

+886-978609292; atonsobek@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: October 3, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: August 30, 2021

Record last verified: 2021-08

Locations

TW (1)