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研究实施负责（组长）单位：
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吉林大学第一医院
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Primary sponsor：
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the First Hospital, Jilin University
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研究实施负责（组长）单位地址：
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吉林省长春市新民大街71号
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Primary sponsor's address：
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No.71, Xinmin Street, Changchun City,Jilin Province, China
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试验主办单位(项目批准或申办者)：
Secondary sponsor：
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国家：
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省(直辖市)：
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市(区县)：
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Country：
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Province：
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City：
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单位(医院)：
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杰华生物技术（北京）有限公司
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具体地址：
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北京市朝阳区利泽中二路望京科技创业园F座5层
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Institution
hospital：
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Genova Biotech Company, Ltd
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Address：
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Building F, 5th Floor, Wangjing Technology Park, Chaoyang District, Beijing 100102
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经费或物资来源：
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杰华生物技术（北京）有限公司，科技部“重大新药创制”课题
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Source(s) of funding：
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Genova Biotech Company, Ltd. , National Novel Drug Development plan
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研究疾病：
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晚期恶性肿瘤患者，包括但不限于胰腺癌、结直肠癌、肝癌、胃癌、非小细胞肺癌、乳腺癌等。
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Target disease：
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Advanced malignant tumors including, but not limited to, pancreatic cancer, colorectal cancer, liver cancer, gastric cancer, non-small cell lung cancer, breast cancer, etc.
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研究疾病代码：
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Target disease code：
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研究类型：
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干预性研究
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Study type：
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Interventional
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研究所处阶段：
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I期临床试验
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Study phase：
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Phase I
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研究目的：
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1. 评估晚期肿瘤患者给予重组高效抗肿瘤抗病毒蛋白注射液的安全性和耐受性。2. 评估重组高效抗肿瘤抗病毒蛋白注射液的药代动力学参数。3.推荐重组高效抗肿瘤抗病毒蛋白注射液 Ⅱ期临床试验给药方案。
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Objectives of Study：
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1.To assess safety and tolerability of Novaferon in Patients with Advanced Cancer.
2. To assess pharmacokinetical parameters of Novaferon.
3. To explore the dosage regimen for the phase Ⅱ trial of Novaferon.
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研究设计：
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非随机对照试验
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Study design：
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Non randomized control
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纳入标准：
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1. 组织学或细胞学诊断证实的晚期、复发或转移的恶性肿瘤患者，包括但不限于胰腺癌、结直肠癌、肝癌、胃癌、非小细胞肺癌、乳腺癌等。2. 既往接受过细胞毒类药物化疗（或介入、靶向治疗）者，终止化疗（或介入、靶向治疗）时间距离登记参加本试验时间间隔至少4周，同时已经从前次化疗（或介入、靶向治疗）的任何毒性反应中恢复过来。3. ECOG行为状态积分（PS）为0～2分。4. 预期生存时间至少12周。5. 年龄18～65岁，性别不限。6. 器官功能水平必须符合下列要求：中性粒细胞绝对计数≥1.5×109/L，血小板≥80×109/L，血红蛋白≥100g/L ，谷草转氨酶和谷丙转氨酶≤2.5倍正常值上限（原发性肝癌、肝转移或胰腺癌，允许AST、ALT≤5倍正常值上限），CCr（内生肌酐清除率）≥60ml/min或Cr（血清肌酐）≤1.5倍正常值上限7. 女性：对于所有可能怀孕的妇女必须采取医学许可的避孕措施且进行妊娠试验，血清或尿妊娠试验必须为阴性，必须为非哺乳期。8. 男性：外科手术绝育或治疗期间及结束后的3个月内采取避孕措施。9. 患者的依从性满足随访的需要。10. 受试者有能力理解和签署知情同意书，必须在进行任何筛选评估前，获得受试者的知情同意。
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Inclusion criteria
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1. Histologically or cytologically confirmed diagnosis of advanced, recurrent or metastatic malignant tumors including, but not limited to, pancreatic cancer, colorectal cancer, liver cancer, gastric cancer, non-small cell lung cancer, breast cancer, etc.
2. At least 4 weeks since prior cytotoxic chemotherapy, interventional therapy or targeted therapy and must have recovered from them completely.
3. ECOG performance status 0-2.
4.Life expectancy ≥ 12 weeks.
5. Subjects must be 18-65 years of age, both male and female.
6. Laboratory values must fulfill all of the following criteria: absolute neutrophil count(ANC) ≥1.5×109/L, platelets≥80×109/L, hemoglobin≥100g/L, AST and ALT≤2.5×upper limit of normal(ULN)( AST and ALT≤5×ULN in the case(s) of primary liver cancer, liver metastases or pancreatic cancer), calculated creatinine clearance(CCr) ≥60ml/min or creatinine(Cr)≤1.5×ULN.
7. Female: Women of childbearing potential must use an approved contraception and must have a negative serum or urine pregnancy test at screening, and must not be breast-feeding.
8. Male: Must be surgically sterile or compliant with an adequate contraception during, and for 3 months after the treatment.
9. Patients compliance with follow-up is required. 10. Ability to understand and the willingness to sign a written informed consent form, the signed informed consent must be obtained prior to performing any study specific procedures.
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排除标准：
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1.已知对干扰素α类药物过敏或已有干扰素α抗体产生者。2.药物成瘾或酒精依赖者。3.在试验用药第一天的前4周内使用了未经批准的药品或其他试验用药。4.合并以下疾病或状况：新近诊断有中枢神经系统转移且未接受手术治疗的患者，严重或不能控制的全身性疾病或任何不稳定的系统性疾病（包括但不限于活动性感染、三级高血压、不稳定心绞痛、充血性心力衰竭、Ⅲ或Ⅳ级心脏病、严重的心律失常、肝肾功能不全或代谢性疾病），既往有明确的神经或精神障碍史等。5.同时接受其他任何抗肿瘤治疗。6.妊娠或哺乳期妇女。
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Exclusion criteria：
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1. Patients with known allergy to interferon-α drugs or already generated interferon-α antibodies.
2. Drug addiction or alcohol dependence.
3. Received any other investigational agents or non-approved drugs within 4 weeks preceding the first dose of investigational product.
4.Having following diseases or conditions: Newly diagnosed CNS metastases without surgery; Any serious , uncontrolled or unstable systematic diseases (including, but not limit to, active infection, grade Ⅲ hypertension, unstable angina pectoris, congestive heart failure, grade Ⅲ or Ⅳ cardiac disease, serious arrhythmia, liver and kidney disorders or metabolic diseases); History of neurologic or psychiatric disorders, etc.
5. Any concurrent anti-tumor therapy during the study.
6. Pregnant or breast-feeding women.
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研究实施时间：
Study execute time：
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从From2009-6-1至To
2009-12-31
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