EUCTR2011-000218-20-BE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: 2012年5月3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. For the purpose of
- •this trial, women of childbearing potential are defined as: All female subjects after puberty unless they are postmenopausal for at least two years, are surgically sterile or are sexually inactive.”
- •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 (< 8 weeks prior to randomization), both, primary or secondary resection (R0 or R1) of all liver metastases. Metastectomy may have been either synchronous or metachronous. Neoadjuvant therapy may have been applied prior to metastasectomy.
- •7. Subject has had a colonoscopy or rectoscopy within the last
- •three months prior to initiation of therapy
- •8. Subject has an ECOG performance status of 0 or 1.
- •9. 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.
- •10. 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 111
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 64
排除标准
- •1. Metastases other than liver metastases.
- •2. R2 and Rx resected liver metastases. Patients with R1 resected liver metastases can be included if a further surgical resection is seen as not indicated or necessary in the surgeon´s opinion.
- •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, MCSF], 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 or newly diagnosed active hepatitis B infection and/or hepatitis C infection, autoimmune hepatitis, 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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