Clinical trial · Interventional
Transarterial Chemoembolization (TACE) With or Without Stereotactic Body Radiotherapy (SBRT) in Hepatocellular Carinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Opened up a separate Clinicaltrials.gov trial form, study ID TACE
Summary
Brief summary (as posted)
Hypothesis: Patients with hepatocellular carcinoma (HCC) have few options if they fail or are unable to undertake surgery, transarterial chemoembolization (TACE) and/or chemotherapy. Radiation (RT) in a range of doses has been combined with TACE in several case cohort studies demonstrating safety and a dramatic improvement in survival. Clearly these trials are subject to bias due to non-randomized selection, possible lack of generalizability to Canadian patients, and heterogeneous patient populations. Objective: Therefore, there is a high priority need to investigate the addition of RT to TACE in a randomized fashion to determine if we can improve survival in this rapidly growing poor prognosis patient population that have no other options. Methodology: TACE eligible patients with HCC will be randomized to TACE alone or TACE plus radiation (TACERT). They cannot be eligible for standard treatments such as transplant and resection. Primary endpoint will be time-to-intrahepatic-progression. Secondary endpoints will be response rate (Modified RECIST criteria), overall survival, local failure, extrahepatic failure, toxicity, quality of life and economic feasibility.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TACE plus RT | Radiation | — | UNRESOLVED |
| transarterial chemoembolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- TACE alone
- description
- Transarterial chemoembolization (TACE)
- interventionNames
- Procedure: transarterial chemoembolization
- type
- EXPERIMENTAL
- label
- TACE plus RT
- description
- Combination of transarterial chemoembolization and radiation (TACERT)
- interventionNames
- Procedure: transarterial chemoembolization
- Radiation: TACE plus RT
Primary outcomes (1)
- measure
- Intrahepatic progression
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 95 Years
Show eligibility criteria text
Inclusion Criteria: * HCC (diagnosed through biopsy or radiological criteria) * Age \>18 years of age * Number of lesions: not more than 3 lesions * Lesion size: up to 10 cm (and up to 10 cm cumulative diameter) * Unilobar +/- segment 4 * Child-Pugh A within 6 weeks prior to study entry * Barcelona Clinic (BCLC) Stage A/B * Absence of comorbidities * ECOG Performance Status 0-2 * Must be fit (eligible) for RT and TACE * Unsuitable/unwilling for resection or transplant or radiofrequency ablation (RFA) or if these options are not available * All blood work obtained within 6 weeks prior to study entry with adequate organ marrow function defined as follows: Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3 Platelets ≥ 50,000 cells/mm3 Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.) Total bilirubin \< 2 mg/dL Prothrombin time/INR \< 1.7 (unless on Coumadin/Warfarin) Albumin ≥ 28 g/L AST and ALT \< 5 times ULN Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60 mL/min * May have had previous surgery, ethanol injection and RFA to the liver * No evidence of metastatic disease including nodal or distant metastases (clinically defined by each institution). * Distance between GTV (lesion) and luminal structures (including esophagus, stomach, duodenum, small or large bowel) is \>5 mm Exclusion Criteria: * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (Note that carcinoma in situ of the breast, oral cavity, or cervix are all permissible). No active cancer therapy. * Major vascular invasion/thrombus * Unsuitable for or refractory to transarterial hepatic chemo-embolization (TACE) Raoul et al (2011) * Previous TACE and radiation to the liver (including SIRT ) * Life-threatening condition including untreated HIV and active hepatitis B/C * Pregnancy or women of childbearing potential require a negative pregnancy test within 28 days
References
Publications (1)
- BACKGROUNDJacob R, Turley F, Redden DT, Saddekni S, Aal AK, Keene K, Yang E, Zarzour J, Bolus D, Smith JK, Gray S, White J, Eckhoff DE, DuBay DA. Adjuvant stereotactic body radiotherapy following transarterial chemoembolization in patients with non-resectable hepatocellular carcinoma tumours of >/= 3 cm. HPB (Oxford). 2015 Feb;17(2):140-9. doi: 10.1111/hpb.12331. Epub 2014 Sep 4. PMID 25186290