Transarterial Chemoembolization with Drug-Eluting Beads (standard arm) versus Stereotactic Body Radiation Therapy (experimental arm) for hepatocellular carcinoma: A multicenter randomized phase II trial *The TRENDY trial*

Phase 2

Recruiting

• Conditions: hepatocellular carcinoma; primary liver cancer; 10019815

• Registration Number: NL-OMON44103
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 64

Inclusion Criteria

-Patients diagnosed with HCC (follow the diagnostic algorithm recommended by the EASL*EORTC Clinical Practice Guidelines 2012). The treatment can be delivered prior to liver transplantation.
-Barcelona Clinic Liver Cancer Stage System class A-B
-One to three tumors with at most up to a cumulative diameter of * 6 cm measured in all 3 axes. In case of multiple lesions, the most favorable setting would be that all are eligible for TACE-DEB. If only one or two lesions are eligible for TACE-DEB, and the others are eligible for ablation, the patient can still be included in the study. Satellite nodules count as independent lesions.
-Earlier treatments with ablation are allowed until a maximum of 3 lesions, including the one, or ones, that will be randomized in the study. Lesions previously treated with ablation should not have exceeded a diameter of 3cm.
-Measurable disease on CT/MRI-scan, according to mRECIST criteria for HCC within 6 weeks prior to randomization
-Tumor visibility on CT
-None or cirrhosis Child-Pugh A
-Age * 18 years
-ECOG performance status 0-1
-Albumin> 28 g/l, bilirubin < 50 µmol/l, INR < 2.3, AST/ALT < 5 times ULN, within 6
weeks prior to randomization
-Platelets will be preferable * 50x10E9/ l (if not, thrombocytes transfusion is allowed to ensure a safe procedure at the discretion of the interventional radiologist and gastroenterologist). Leukocytes > 1.5x10E9/l, Hb > 6 mmol/l, within 6 weeks prior to randomization
-Written informed consent
-Willing and able to comply to the follow-up schedule
-Planned to start treatment within 6 weeks from randomization.

Exclusion Criteria

-Eligibility for resection or RFA
-More than three tumors in the liver
-Ascites
-Any signs of acute viral or non-viral hepatitis
-Encephalopathy
-Vascular tumor invasion (contact with the vessel will not be considered contraindication).
-Previous radiotherapy to the liver
-Known current pregnancy
-Distance from the tumor to the esophagus, stomach, duodenum, small bowel or large bowel < 0.5 cm on CT or on MRI (randomization imaging).
-Uncontrolled portal hypertension (high bleeding risk). If gastroscopy has been performed, untreated esophageal varices grade III or IV.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of this study will be time to progression, defined as time<br /><br>from randomization to radiological progression. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints will be:<br /><br>-Time to local recurrence<br /><br>-Response rate (complete and partial response)<br /><br>-Overall survival<br /><br>-Toxicity<br /><br>-Quality of life.</p><br>