EUCTR2011-000218-20-DE进行中（未招募）1 期
ICC: L-BLP25 in Patients with Colorectal Carcinoma after curative resection of hepatic metastases – a randomized, placebo-controlled, multicenter, multinational, double blinded phase II trial - LICC
niversitätsmedizin Mainz0 个研究点目标入组 121 人开始时间: 2011年5月30日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 121
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed written informed consent.
- •2. Male or female.
- •3. At least 18 years of age.
- •4. Female patients of childbearing potential (and if appropriate male patients with female partners of childbearing potential) must be willing to use an adequate method of contraception for 4 weeks prior to, during and 12 weeks after the last dose of trial medication. A negative pregnancy test is required for female subjects. Adequate contraception for female subjects is defined as two barrier methods, or one barrier method with a spermicide, or intrauterine device or use of hormonal female contraceptive.
- •5. Histologically confirmed diagnosis of adenocarcinoma of the colon or rectum with complete resection of primary tumor and no evidence of local relapse.
- •6. Metastatic disease of the liver, with recent (< 6 weeks prior to randomization) resection (R0 or R1) of all liver metastases. Metastasectomy may have been either synchronous or metachronous. Any neoadjuvant therapy may have been applied for maximal 3 months prior to metastasectomy.
- •7. Subject has an ECOG performance status of 0 or 1.
- •8. Subject has adequate hematologic, hepatic, and renal function within 2 weeks prior to initiation of therapy as defined by the following:
- •-Absolute neutrophils > 1,500/mm3 and platelets > 140,000/mm3.
- •-Bilirubin < 1.5 x upper limit of normal (ULN).
- •-AST and ALT < 2.5 x ULN.
- •- Creatinine < 1.5 x ULN.
- •- International Normalized Ratio (INR) and partial thromboplastin time (PTT) in the normal range of the local lab respectively within therapeutic range in case of anticoagulation .
- •9. Willingness to comply with study protocol requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 84
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 37
排除标准
- •1. Metastases other than liver metastases.
- •2. R2 and Rx resected liver metastases.
- •3. Chemotherapy within 4 weeks prior to randomization
- •4. Receipt of immunotherapy (e.g. interferons, tumor necrosis factor, interleukins, or growth factors [GM-CSF, G-CSF, M- CSF], monoclonal antibodies) within 4 weeks (28 days) prior to randomization.
- •5. Any known autoimmune disease, past or current.
- •6. A recognized immunodeficiency disease including cellular immuno-deficiencies, hypogammaglobulinemia or dysgammaglobulinemia; hereditary or congenital immunodeficiencies.
- •7. Known active hepatitis B infection and/or hepatitis C infection, known human immunodeficiency virus infection, or any other infectious process that in the opinion of the investigator could compromise the subject’s ability to mount an immune response, or expose him/ her to likelihood of more and/or severe side effects.
- •8. Past or current history of malignant neoplasm other than CRC, except for curatively treated non-melanoma skin cancer, in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years.
- •9. Medical or psychiatric conditions that would interfere with ability to provide informed consent, communicate side effects, or comply with protocol requirements.
- •10. Clinically significant cardiac disease, e.g. cardiac failure of New York Heart Association classes III-IV; uncontrolled angina pectoris, uncontrolled arrhythmia, uncontrolled hypertension, myocardial infarction in the previous 12 months as confirmed by an ECG.
- •11. Splenectomy.
- •12. Previous (less than 4 weeks prior to randomization) or concurrent treatment with a non-permitted drug.
- •13. Pregnancy and lactation period.
- •14. Participation in another clinical study within 30 days prior to randomization.
- •15. Known hypersensitivity to the study treatment drugs.
- •16. Known alcohol or drug abuse.
- •17. Legal incapacity or limited legal capacity.
- •Any other reason that, in the opinion of the investigator, precludes the subject from participating in this study.
研究者
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