Safety and effectiveness of the nimotuzumab in tumors of head and neck in advanced stages, again diagnosis or recurrent.

Center of Molecular Immunology (CIM)0 个研究点目标入组 404 人开始时间: 2013年2月1日最近更新: 2024年8月19日

适应症

试验速览

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研究类型: Interventional
分配方式: Non-randomized controlled trial. Masking: Open. Control group: Uncontrolled. Assignment: Other. Purpose: Treatment

•1.Patient that expresses the voluntary written into the studio with the signing of the informed consent. 2.Patient with age equal or greater than 18 years. 3.Expectation of life equal to or greater than 6 months. 4.Clinical status according to criteria of the ECOG less than or equal to 3. 5.Laboratory parameters(considering type of processing and equipment used): Hematopoietic - hemoglobin (Hb) greater than or equal to 100g/L hematocrit 0.30-0.40 in women and 0.30-0.44 in men, count of leukocytes ? 3000/?L = 3 x 109 L, CAN ? 1500/?L = 1.5 x 109 /L, platelets count greater than or equal to 100000/?L = 100 x 109 L, biochemical-liver: ALAT (TGP), ASAT (TGO), alkaline phosphatase, up to 2.5 times upper limit of normal for each clinical site; LDH and albumin normal value; Kidney: serum creatinine normal value.

•1.Pregnancy, postpartum or breastfeeding. 2.Chronic disease associated in stage of decompensation (example: heart disease, diabetes mellitus, arterial hypertension). 3.Brain metastasis, diagnosed by TAC, not controlled or in progression. 4.Presence of a second primary tumor, with the exception of basal carcinomasor squamous skin and carcinoma in situ treated neck. 5.Patient who is receiving another investigational medicinal product at the time of inclusion. 6.Treatment with nimotuzumab in the 6 months prior to the time of inclusion. 7.Prior knowledge of allergy or sensitivity to the nimotuzumab or any component of the formulation.

发起方

Center of Molecular Immunology (CIM)