NL-OMON50334已完成3 期
A Phase III Clinical Trial of Intra-arterial TheraSphere® in the Treatment of Patients with Unresectable Hepatocellular Carcinoma (HCC). - TheraSphere® in Unresectable Hepatocellular Carcinoma (HCC). STOP-HCC
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 38
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
- •1. Must have signed informed consent prior to any study-related evaluation
- •2. Must be male or female patients over 18 years of age
- •3. Must have unresectable HCC confirmed by histology or by non-invasive AASLD10
- •4. Must have measurable disease defined as at least one uni-dimensional
- •measurable lesion by CT
- •or MRI (according to RECIST 1.1)
- •5. Must have a Child Pugh score <= 7 points
- •6. Must have an ECOG Performance Status score of <= 1
- •7. Must have a Life expectancy of 12 weeks or more
- •8. Must have be eligible to receive SOC sorafenib
- •9. Must have Platelet count > 50 x 109/L or > 50% prothrombin activity
- •10. Must have Hemoglobin >= 8.5 g/dL
- •11. Must have Bilirubin <= 2.5 mg/dL
- •12. ALT and AST must be < 5X upper limit of normal
- •13. Amylase or lipase must be <= 2X upper limit of normal
- •14. Serum creatinine must be <= 1.5X upper limit of normal
- •15. INR must be <= 2.0
排除标准
- •16. Must not have main PVT (branch portal vein thrombosis is permissible).
- •17. Must not be eligible for curative treatment (e.g ablation or
- •transplantation)
- •18. Must not have a history of previous or concurrent cancer other than HCC
- •unless treated curatively 5 or more years prior to entry
- •19. Must not have confirmed presence of extra-hepatic disease with the
- •exception of lung nodules
- •and mesenteric or portal lymph nodes <= 2.0 cm each
- •20. Must not be at risk of hepatic or renal failure
- •21. Must not have tumor replacement >70% of total liver volume based on visual
- •estimation by the
- •investigator OR must not have tumor replacement >50% of total liver volume in
- •the presence of
- •albumin <3 g/dL
- •22. Must not have any history of severe allergy or intolerance to contrast
- •agents, narcotics sedatives
- •or atropine that cannot be managed medically
- •23. Must not have any contraindications to angiography and selective visceral
- •catheterization
- •24. Must not have history of organ allograft
- •25. Must not have any known contraindications to sorafenib including
- •allergic reaction, pill-swallowing difficulty, evidence of severe or
- •uncontrolled
- •systemic diseases, uncontrolled severe hypertension or cardiac
- •arrhythmias, congestive heartcardiac failure >New York Heart Association (NYHA)
- •class 2, myocardial infarct within 6 months, prolonged QT/QTc >450ms, evidence
- •of torsades de
- •pointe, 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, metastatic brain disease, renal failure requiring dialysis.
- •26. Must not be taking any of the following: Rifampicin, St. John*s Wort,
- •phenytoin, carbamazepine,
- •phenobarbital, and dexamethasone
- •27. Must not be taking any other systemic anticancer agent (e.g docetaxel,
- •doxorubicin, irinotecan etc)
- •28. Must not be taking substrate agents for CYP2B6 (buproprion,
- •cyclophosphamide, efavirenz,
- •ifosfamide, methadone, pacilitaxel, amodiaquine, repaglinide)
- •29. Must not be taking UGT 1A1 and UGT 1A9 substrates (e.g., irinotecan)
- •30. Must not be taking P-Gp substrates (e.g., Digoxin)
- •31. Any prior liver resection must have taken place > 2 months prior to
- •randomization
- •32 Treatment with other locoregional therapies (other than study treatment) has
- •not been planned
- •for the duration of the clinical study period
- •33 Has not received any prior external beam radiation treatment to the chest,
- •liver or abdomen
- •34. Has not received any prior yttrium-90 microsphere treatment to the liver
- •35. Prior treatment with transarterial chemoembolization (TACE) or bland
- •embolization must have
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