NL-OMON44103招募中2 期
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* - TRENDY trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •-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.
排除标准
- •-Eligibility for resection or RFA
- •-More than three tumors 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 < 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.
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