Clinical trial · Interventional
Clinical Trial Comparing TACE With TACE + SABR in Stage BCLC B HCC (HepSTAR)
Randomized Controlled Phase II Trial Comparing Trans-Arterial Chemo-Embolization (TACE) With TACE Plus Stereotactic Ablative Radiotherapy (SABR) in Stage BCLC B Hepatocarcinoma (HepSTAR)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of recruitment
Summary
Brief summary (as posted)
This will be multicentre a phase II randomized controlled and open-label trial. It will compare the 6-months objective response (CR+PR) rates obtained with Drug Eluting Bead Trans-Arterial Chemo-Embolization (DEB-TACE) alone versus DEB-TACE followed by Stereotactic Ablative Radiotherapy (SABR) in patients with hepatocarcinoma stage BCLC B. This trial will also include one substudy. This substudy will confront the immuno-histochemical results collected on tumoral biopsies to the biological and imaging (MRI) results. Every patient participating to the trial can also participate to this substudy.
Conditions
Conditions (2)
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 Cancer | Hepatocellular Carcinoma | CURATED_BROADER | 0.80 |
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Stereotactic Ablative Radiotherapy | Radiation | — | UNRESOLVED |
| Trans-arterial Chemo-Embolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Trans-Arterial Chemo-embolization (TACE)
- description
- Trans-arterial Embolisation will be performed with drug-eluting beads loaded with Doxorubicin. First session will be given within 4 weeks after randomization. 4-phase MRI will be performed every 2 months to assess the response. In case of insufficient response according to the MRI performed at 2 or 4 months, a second or third session of DEB-TACE will be allowed, according to the physician's choice. Once complete response is achieved, the follow-up period will start. The date of the last session of TACE corresponds to the treatment completion date.
- interventionNames
- Procedure: Trans-arterial Chemo-Embolization
- Drug: Doxorubicin
- type
- EXPERIMENTAL
- label
- TACE+Stereotactic Ablative Radiotherapy
- description
- The first part of the treatment, which is the DEB-TACE delivery, will be exactly the same than in arm A. The radiotherapy (SABR) will then start within 4 to 6 weeks after. Afterwards, 4-phase MRI will be performed every 2 months to assess the response. In case of insufficient response according to the MRI performed at 2 or 4 months, a second or third session of DEB-TACE will be allowed, according to the physician's choice. Once complete response is achieved, the follow-up period will start. The date of the last SABR fraction or the last session of TACE corresponds to the treatment completion date.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Hepatocellular carcinoma larger than 3 cm and non-resectable, with a diagnosis established either by: * dynamic imaging (non-invasively), showing a typical contrast enhancement and wash-out * histopathology * satellite lesions are allowed (at most three lesions) as long as the doses constraints are still achievable * Hepatocellular carcinoma belonging to Barcelona Clinic Liver Cancer Stage System class B * Tumor must be measurable on a multi-phase MRI according to mRECIST criteria * Non-tumoral liver volume ≥ 800 cc * Child-Pugh (CP) A to B7 cirrhosis * HCC Patients can be included if they require treatment prior to liver transplantation * ECOG performance status 0-1 * AST/ALT \< 5 times ULN * Initial platelets ≥ 50 000 x 10E9/l, neutrophils \> 1500 x 10E9/l, Hb \> 9 g/dl * Serum creatinine \< 1.5 X normal, or calculated Creatinine clearance rate ≥ 60 mL/min * As tumor biopsy can be performed after inclusion, pure hepatocellular carcinoma but also mixed hepatocellular carcinoma will be allowed in this trial. Cholangiocarcinoma cannot be included. * Written informed consent form to be signed, * Patient willing and able to comply to the follow-up schedule * Patients in fertile age should use a contraceptive method during treatment and 4 months after. Exclusion Criteria: * Eligibility for resection or ablative treatments * Extra hepatic spread of the disease * Previous treatment of the same lesion with TACE * Previous treatment with selective internal radiotherapy or radiotherapy to the upper abdomen * Uncontrolled Ascites * Uncontrolled Encephalopathy * Any clinical sign of acute viral or non-viral hepatitis (new serological testing are not required) * Known current pregnancy * Uncontrolled active co-morbidity
References
Publications (0)
Data not yet available