NCT02293850Unknown1 期
A Phase I Study to Evaluate the Safety and Efficacy of Telomelysin (OBP-301) in Patients With Hepatocellular Carcinoma
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Evaluation of safety parameters (adverse events, laboratory data, EKG, body weight, vital signs) on patient-base.
研究概览
简要总结
This is an open labeled, multiple centers, two countries (Taiwan and Korea) non-comparative phase I trial in patients with hepatocellular carcinoma. In phase I part, a maximum of 18 patients will be recruited in this study.
详细描述
After screening, each eligible patient will undergo a treatment of OBP-301 within 14 days and will automatically enter follow-up period.
The follow-up period is up to 12 weeks after the last injection in the phase I part.
Each patient will return for follow-up visit weekly in the first month after the last injection, and then every 4 weeks up to the end of follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 65 years (19 to 65 years in Korea), either sex
- •Patients diagnosed with hepatocellular carcinoma. The diagnosis of HCC (hepatocellular carcinoma) should be established by cytology or histopathology
- •Patients who have unresectable HCC and meet all of the following conditions:
- •Barcelona Clinic Liver Cancer (BCLC) stage B or C
- •TransAarterial ChemoEmbolization (TACE) refractory in discretion of the investigators, or TACE unsuitable (such as but not limited to portal vein thrombosis)
- •Local ablative treatment (such as percutaneous ethanol injection, radiofrequency ablation, etc) unsuitable
- •Sorafenib failure, intolerable or ineligible
- •Patients must have at least one lesion that can be accurately measured in at least one dimension as 1 cm or more and the lesion must be suitable for repeat measurement
- •Patients who have Child-Pugh's Score no greater than 7, and have no ascites
- •Patients who have all the conditions below at screening:
- •serum ALT (Alanine Aminotransferase) level (GPT) less than 2.5 x UNL
- •serum AST (Aspartate Aminotransferase) level (GOT) less than 2.5 x UNL
- •WBC (white blood cell) greater than or equal to 3,000 / microliter
- •Serum creatinine less than or equal to 1.5 x UNL
- •activated partial thromboplastin time (APTT) <1.5 x UNL
- •Platelet count correctable to greater than or equal to 80,000 / microliter
- •prothrombin time-international normalized ratio (PT-INR) correctable to less than 1.5
- •Patients who have life expectancy longer than 12 weeks
排除标准
- •Patients who have had chemotherapy within last three weeks (6 weeks for nitrosourea or Mitomycin-C) prior to dosing
- •Patients who have had radiotherapy to tumor site within the last four weeks prior to dosing and with documentation of subsequent tumor growth at this site
- •Patients who have received other investigational or antineoplastic medication within the last four weeks prior to dosing
- •Patients who had history of esophageal variceal bleeding within eight weeks prior to study entry
- •Patients who have uncontrolled diabetes, active or chronic infection, including HIV, except for asymptomatic bacterial colonization, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection
- •Patients who had acute viral infection syndrome diagnosed within the last two weeks
- •Patients who have concomitant hematological malignancy (e.g. acute lymphocytic leukemia, non-Hodgkin's lymphoma)
- •Patients who have active rheumatoid arthritis or other autoimmune disease.
- •Patients who have current requirement for chronic systemic immunosuppressive medication including any dose of glucocorticoid or cyclosporin, or chronic use of any such medication within the last four weeks Note: Course of glucocorticoid therapy less than 10 days duration is allowed (e.g. for nausea control)
- •Patients with organ transplants (may require prolonged immunosuppressive therapy)
- •Patients who had prior participation in any research protocol which involved administration of adenovirus vectors
- •Patients received any immune-related related related related related blood products, such as immunoglobulin in the prior 3 months
- •Patients who have uncontrolled concurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Psychiatric, addictive, or any disorder which compromises ability to give truly informed consent for participation in this study or adequate compliance
- •Female patients that are pregnant or on breast-feeding
- •Patients who receive anti-platelet agents or anti-coagulation agents (e.g. Heparin, warfarin, aspirin, ticlopidine, clopidogrel, dipyridamole and so on).
研究组 & 干预措施
single intra-tumoral injection
Experimental
OBP-301 ; Cohort 1: 1x10 10 viral particle (VP)/ tumor Cohort 2: 1x10 11 viral particle (VP)/ tumor Cohort 3: 1x10 12 viral particle (VP)/ tumor
干预措施: OBP-301 (Biological)
结局指标
主要结局
Evaluation of safety parameters (adverse events, laboratory data, EKG, body weight, vital signs) on patient-base.
时间窗: 14 weeks
次要结局
- Dose-Limiting Toxicity (DLT) for patients using OBP-301.(28 weeks)
- Maximum Tolerated Dose (MTD)/ Maximum Feasible Dose (MFD) for patients using OBP-301.(16 weeks)
研究者
研究点 (4)
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