NCT01556490已完成不适用
A Phase III Clinical Trial of Intra-arterial TheraSphere® in the Treatment of Patients With Unresectable Hepatocellular Carcinoma (HCC)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 526
- 试验地点
- 178
- 主要终点
- Overall Survival (OS) Results Are Based on the Modified Intent-to-treat (mITT)
研究概览
简要总结
The safety and effectiveness of TheraSphere will be evaluated in patients with unresectable hepatocellular carcinoma in whom treatment with standard-of-care sorafenib is planned. All patients receive the standard-of-care sorafenib with or without the addition of TheraSphere.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent prior to any study-related evaluation
- •Male or female patients over 18 years of age
- •Unresectable HCC confirmed by histology or by non-invasive AASLD criteria
- •Measurable disease defined as at least one uni-dimensional measurable lesion by CT or MRI according to RECIST 1.1
- •Child Pugh score ≤ 7 points
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of ≤ 1
- •Life expectancy of 12 weeks or more
- •Eligible to receive standard-of-care sorafenib
- •Platelet count of > 50 x 10⁹/L or > 50% prothrombin activity
- •Hemoglobin ≥ 8.5 g/dL
- •Bilirubin ≤ 2.5 mg/dL
- •Alanine transaminase (ALT) and Aspartate Aminotransferase (AST)< 5 X upper limit of normal
- •Amylase or lipase ≤ 2X upper limit of normal
- •Serum creatinine ≤ 1.5 X upper limit of normal
- •International normalized ratio (INR) < 2.0
排除标准
- •Main portal vein thrombosis
- •Eligible for curative treatment (ablation or transplantation)
- •History of previous or concurrent cancer other than HCC unless treated curatively 5 or more years prior to entry
- •Confirmed presence of extra-hepatic disease except lung nodules and mesenteric or portal lymph nodes ≤ 2.0 cm each
- •Risk of hepatic or renal failure
- •Tumor replacement ≥ 70% of total liver volume based on visual estimation by investigator OR tumor replacement ≥ 50% of total liver volume in the presence of albumin <3 mg/dL
- •History of severe allergy or intolerance to contrast agents, narcotics sedatives or atropine that cannot be managed medically
- •Contraindications to angiography and selective visceral catheterization.
- •History of organ allograft
- •Known contraindications to sorafenib including allergic reaction, pill-swallowing difficulty, evidence of severe or systemic diseases, uncontrolled severe hypertension or history of cardiac arrhythmias, congestive heart failure . New York Heart Association 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
- •Taking any of the following: Rifampicin, St. John's Wort, phenytoin, carbamazepine, phenobarbital, dexamethasone
- •Taking any other systemic anticancer agent (docetaxel, doxorubicin, irinotecan)
- •Taking any substrate agents for Cytochrome P450 (CYP) 2B6 (bupropion, cyclophosphamide, efavirenz, ifosfamide, methadone, paclitaxel, amodiaquine, repaglinide)
- •Taking any UDP-glucuronosyltransferase (UGT) 1A1 and UGT 1A9 substrates (e.g. irinotecan)
- •Taking P-Gp substrates (e.g. Digoxin)
- •Prior liver resection must have taken ≥2 months prior to randomization
- •Treatment with other locoregional therapies (other than study treatment) has not been planned for the duration of the clinical study period
- •Prior external beam radiation treatment to the chest, liver or abdomen
- •Prior yttrium-90 microsphere treatment to the liver
- •Prior treatment with transarterial chemoembolization (TACE) or bland embolization must have occurred >2 months prior to randomization and must have been applied to a treatment field and/or lobe not targeted for treatment under this protocol. For patients with tumor progression in the treatment field and /or lobe previously treated with TACE, vessels feeding the tumor(s) must be assessed for adequate blood flow using angiography (cone beam computerized tomography (CBCT) strongly recommended), and TACE or bland embolization must have been applied >6 months prior to randomization.
- •Anti-cancer therapy or any treatment with an investigational agent within 30 days prior to randomization
- •Adverse effects due to prior therapy unresolved at randomization
- •Prior systemic treatment for the treatment of HCC, including sorafenib given for more than 4 weeks during the 2 previous months prior to randomization, no prior sorafenib related toxicity
- •Evidence of pulmonary insufficiency or inadequately treated moderate grade or severe/very severe grade chronic obstructive pulmonary disease
- •Intervention for, or compromise of, the Ampulla of Vater
- •Clinically evident ascites (trace ascites on imaging is acceptable)
- •Pregnancy or breast feeding
- •Women of child-bearing potential must have a negative serum pregnancy test within 14 days prior to randomization
- •Disease or condition that would preclude safe use of TheraSphere, including concurrent dialysis treatment, or unresolved serious infections. Patients infected with HIV can be considered, however, they must be well managed and well controlled with undetectable viral load
- •Participation in concurrent clinical trials evaluating treatment intervention(s)
结局指标
主要结局
Overall Survival (OS) Results Are Based on the Modified Intent-to-treat (mITT)
时间窗: From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an average of 16.3 months
Time from randomization until date of death due to any cause as reported by study site.
Overall Survival (OS) Per Protocol (PP) Population
时间窗: From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an average of 16.3 months
Per Protocol = subset of the mITT population excluding patients with major protocol deviations which may affect the efficacy evaluation.
次要结局
- Time to Untreatable Progression (TTUP) From the Time of Randomization Based One or More of the Following: Investigator Assessment According to RECIST Criteria(From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an average of 16.3 months)
- Tumor Response(From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an average of 16.3 months)
- Time to Progression (TTP) From Time of Randomization Based on Investigator, According RECIST Criteria.(From time of randomization up to date of death or last date known to be alive (data cut-off 30Apr2022), an average of 16.3 months)
研究者
研究点 (178)
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