EUCTR2012-005375-14-BE进行中（未招募）1 期
A prospective randomized clinical trial on 90Yttrium trans-arterialradio-Embolization (Therasphere) vs. standard of care (sorafenib)for the treatment of advanced Hepatocellular carcinoma (HCC)with Portal Vein Thrombosis (PVT) - YES-P
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 318
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients over 18 years of age, regardless of race or gender
- •2. Advanced stage HCC confirmed by histology (mandatory in non cirrhotic patients) or non-invasive criteria (EASL/AASLD) with branch PVT.
- •-Either naïve or recurrent HCC after curative treatment (minimum 6 3 months from curative treatment - minor resection or local ablation) is acceptable.
- •-Branch PVT classified as Type I, Type II or Type IIIa (see Section 9.2.5).
- •3. Unilobar disease as defined in Section 8.1.
- •4. Tumor volume = 70% of liver volume (determined by visual estimation)
- •5. Child-Pugh A
- •6. At least one uni-dimensional HCC target lesion assessable according to the RECIST v1.1 criteria by CT-scan or MRI
- •7. No confirmed extrahepatic metastases. Patients with indeterminate hepatic hilar lymph nodes up to 2.5 cm in greatest dimension, or with indeterminate lung nodules (single lesion between 1-1.5cm, or multiple smaller lesions with a total diameter = 2 cm) may be included if metastatic disease is deemed unlikely
- •8. No known contraindications to standard-of-care sorafenib including allergic reaction, pill swallowing difficulty, uncontrolled hypertension or history of cardiac disease (according to sorafenib package insert and country-specific policies, may include evidence of severe or uncontrolled systemic diseases, cardiac arrhythmias (requiring anti-arrhythmic therapy or pace maker), congestive cardiac failure >New York Heart Association class 2, myocardial infarct within 6 months, prolonged QT/QTc >450ms), or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial uncontrolled hypertension or history of cardiac disease, significant GI bleed within 30 days, renal failure requiring dialysis
- •9. No evidence of hepatic vein invasion or caval thrombosis
- •10. Cancer-related symptoms within the ECOG 0-1 category
- •11. PLT = 50 x103/µL
- •12. WBC = 1.5 x103/µL
- •13. AST/ALT = 5 times the upper limit of normal (U/L)
- •14. Creatinine = 2.0 mg /dL
- •15. No evidence of pulmonary insufficiency or clinically evident chronic obstructive pulmonary disease.
- •16. No indication for any possible curative treatment after multidisciplinary assessment (surgery, ablation, transplantation)
- •17. No previous treatment with Sorafenib for more than 4 weeks during the 2 previous months; no prior sorafenib-related toxicity at any dose and/or duration defined as documented sorafenib-related grade 3 or 4 adverse events that led to sorafenib discontinuation
- •18. No initiation of any other anti-tumor therapy including chemotherapy, radioembolization (maximum lung shunt of 20% for prior radioembolization) or investigational drug treatment within 30 days before the beginning of the study
- •19. In case of patients progressing from an intermediate to an advance stage because of occurrence of PVT, enrolment is allowed if previous conventional or drug eluting TACE was performed at least 6 3 months prior to screening phase
- •20. Patients cannot be on a liver transplantation list
- •21. No history of organ allograft
- •22. No contraindication to angiography or selective visceral catheterization
- •23. No history of severe allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically
- •24. No previous external beam radiation treatment to the liver
- •25. No evidence of continuing adverse effect of prior therapy
- •26. No active GI bleeding and any bleeding diathesis or coagulopathy that is not cor
排除标准
- •Not applicable
研究者
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