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

Erasmus MCDepartment of Radiotherapy0 个研究点目标入组 100 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

暂无简介。

•In order to be eligible to participate in this study, a subject must be discussed in a multidisciplinary liver tumor board and should meet all of the following criteria:
•Patients diagnosed with HCC (follow the diagnostic algorithm recommended by the
•EASL–EORTC Clinical Practice Guidelines 2012) [1].
•Barcelona Clinic Liver Cancer Stage System class A-B
•One tumor of maximum diameter ≤ 6 cm measured in all 3 axes. A maximum of two satellite nodules around the main tumor are accepted. Satellite nodules should fulfill the following criteria: Distance from the main tumor to the inner border of the nodules should be < 1 cm, maximum diameter of each nodule should be ≤ 5 mm, maximum diameter of the main tumor together with the nodules should be ≤ 6 cm in all 3 axes.
•Measurable disease on CT/MRI-scan, according to mRECIST criteria for HCC within 6 weeks prior to randomization [44].
•Tumor visibility on CT
•Child-Pugh A cirrhosis
•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 ≥ 50x10E9/ l, neutrophils > 0.75x10E9/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.

•A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Eligibility for resection or RFA
•More than one tumor in the liver
•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 < 2 cm on CT or on MRI. Uncontrolled portal hypertension (high bleeding risk). If gastroscopy has been performed, untreated esophageal varices grade III or IV.

发起方

Erasmus MCDepartment of Radiotherapy