Clinical trial · Interventional
Adjuvant Stereotactic Body Radiation Therapy After Trans-arterial Chemoembolization in Hepatocellular Carcinoma
NCT04996914CI-TRIAL-00110997ASTrHrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study investigates the adjuvant SBRT following TACE in early and intermediate stages HCC not amenable for surgical resection.
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 Non-resectable | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT | Radiation | — | UNRESOLVED |
| TACE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TACE+SBRT.
- description
- If a patient is eligible to participate in the project according to the in- and exclusion criteria, the patient will assigned to 1-2 sessions of TACE followed by SBRT within one month from last TACE session .
- interventionNames
- Procedure: TACE
- Radiation: SBRT
Primary outcomes (1)
- measure
- 1-year local control rate
- timeFrame
- 12 Months
- description
- After one year from the treatment, the precentage with alive subjects with no signs of local progression (the irradiated lesion). Local progression defined as more than 20% increase in diameter of enhancing tumor on contrast-enhanced CT scan in arterial phase or a new tumor mass within the original tumor volume according to modified RECIST criteria (mRECIST)
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * HCC (diagnosis: histological or radiological) * Age: 18-80 * Number of lesions 1-3 lesions * Size of the lesion (or sum of 2-3 lesions) ≥ 4 cm * Sufficient non-tumorous liver volume (≥ 800 cm3) * Child Pugh Score: A5-6 or B7-8 * BCLC A or B * Patient is illegible or refused surgical resection or orthotopic liver transplant * Blood work (within 2 weeks before registration): * Absolute neutrophil count (ANC) ≥ 1,500 cells/mm³) * Platelets ≥50,000 cells/mm³ * AST (and ALT) \< 5 times ULN * Serum creatinine ≤ ULN or creatinine clearance ≥ 50 mL/min Exclusion Criteria: * Evidence of extrahepatic disease (lymph node or distant metastases) * Evidence of macroscopic vascular invasion * Evidence of an arterio-portal or arterio-venous fistulas * History of previous malignancy * Previous SIRT * Previous Sorafenib in the last 8 weeks * Pregnant and lactating females
References
Publications (0)
Data not yet available
No reference posted for this study.