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New treatment option for Hepatocellular Carcinoma Non-resectable
Official title Adjuvant Stereotactic Body Radiation Therapy After Trans-arterial Chemoembolization in Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT04996914
What this study is testing
- What it's testing
- The study investigates the adjuvant SBRT following TACE in early and intermediate stages HCC not amenable for surgical resection.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aachen, North Rhine-Westphalia, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aachen, North Rhine-Westphalia, Germany. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.