EUCTR2012-005375-14-GB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.
- •o Either naïve or recurrent HCC after curative treatment (minimum 3 months from curative treatment - minor resection or local ablation) is acceptable.
- •o 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 , 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 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 correctable by usual therapy or hemostatic agents (e.g., cl
排除标准
- •Not applicable
研究者
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