NCT01640808已完成3 期
NIK-333(Peretinoin) PhaseⅢ Study Investigation of the Efficacy and Safety to Suppress Recurrence of Hepatitis C Virus(HCV)-Positive Hepatocellular Carcinoma(HCC), Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel-group Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 616
- 主要终点
- Recurrence-free Survival
研究概览
简要总结
The purpose of this study is to verify the superiority of NIK-333 (Peretinoin) to placebo in inhibiting the recurrence of HCV-positive HCC in patients showing complete cure of the disease, with the recurrence-free survival as the primary endpoint, in a multi-center, randomized, double-blind, placebo-controlled, parallel-group comparison study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with HCV-positive HCC who meet the following conditions before radical treatment
- •Patients diagnosed as having typical HCC on dynamic CT,CTA/CTAP, or dynamic MRI (nodule visualized as a high signal intensity area in the arterial phase and as a relatively low signal intensity area in the portal and equilibrium phases) performed within 8 weeks (56 days) before treatment start prior to radical therapy
- •Patients with the first primary HCC or the first recurrence of primary HCC
- •Patients who received the radical therapies. The treatment duration (from the start to the end of the treatment) should be within 4 weeks (28 days) for each of the radical therapies.
- •Patients showing a complete cure, as confirmed by the dynamic CT images taken from 8 weeks (56 days) to 12 weeks (84 days) after the end of the treatment show a non-stained low-concentration area overlapping the tumor image observed before complete cure.
- •Patients who are able to begin treatment with the study drug within 8 weeks (56 days) after dynamic CT to confirm complete cure
- •Patients confirmed of satisfying the following conditions based on the screening performed at subject registration
- •Positive for serum hepatitis C virus nucleic acid (HCV-RNA)
- •Grade A on Child-Pugh classification
- •Platelet count of 50 000/µL or higher
- •Patients with ECOG Performance Status score of 0 to 1
- •Patients of the age of 20 years or older at the time of informed consent
排除标准
- •Patients positive for HBs antigen
- •Patients showing vascular invasion of HCC on imaging diagnosis
- •Patients who have also undergone transcatheter arterial embolization therapy (TAE/TACE), transarterial infusion therapy (TAI), and chemolipiodolization in combination with the radical therapy
- •4 Patients who want to receive antiviral therapy such as concomitant therapy with intaferon during the study period
- •Patients who have received other study drugs, anticancer drugs, or interferons after radical therapy
- •Patients who have hypertension as a complication, and whose blood pressure cannot be controlled by drug therapy (systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher, as determined at subject registration)
- •Patients who have a history of allergy to CT contrast media, and whose participation in this study is judged to be inappropriate by the investigator or the subinvestigator
- •Patients with a history of total gastrectomy
- •Patients with a history of cardiac arrest
- •Patients with any of the following laboratory values or complications
- •Creatinine>= 1.5mg/dL
- •Albumin urine >= 1000mg/g Creatinine
- •Cardiac disorder corresponding to CTC-AE grade 3 in severity
- •HbA1c >= 7.4 under treatment with insulin
- •Autoimmune disease or asthma being treated with oral steroid
- •Patients confirmed of having another malignant neoplasm or who had undergone a radical therapy of HCC within the past 5 years to treat another malignant neoplasm (however, this does not apply to endoscopic resection and resection of intraepithelial carcinoma)
- •Patients who are pregnant, who have a possibility of being pregnant or who have a desire to become pregnant during the study period
- •Lactating women
- •Patients who have a history of allergy to retinoid-related substances (vitamin A, etc.) in the past
- •Patients who participated in another clinical study within past 6 months
研究组 & 干预措施
NIK-333(peretinoin)
Experimental
干预措施: NIK-333(peretinoin) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Recurrence-free Survival
时间窗: Date of randomization to the date of recurrence of HCC (followed every 12 weeks) or death (whichever occurs first)
HCC recurrence was defined as the appearance of new intrahepatic lesions which was confirmed based on findings of hypervascularity (nodules enhanced in the arterial phase and washout in the late phase) by dynamic CT images, or a new extrahepatic metastasis. Recurrence of intrahepatic HCC was evaluated by an independent image reading committee. RFS was defined as the time from randomization to HCC recurrence or death from any cause, whichever occurred first. For subjects who terminated the study without HCC recurrence or death, RFS was censored at the day of the latest dynamic CT examination.
次要结局
- Disease-free Survival(Date of randomization to the date of recurrence of HCC (followed every 12 weeks), death, or secondary cancer (malignant tumors other than HCC)(whichever occurs first))
- Time to Recurrence(Date of randomization to the date of recurrence of HCC(followed every 12 weeks))
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