se of monoclonal antibody Nimotuzumab and radio-chemotherapy in the treatment of patients with locally advanced head and neck cancer - PL013 N-CRT-CC

Center of Molecular Immunology (CIM)0 个研究点目标入组 30 人开始时间: 2017年2月17日最近更新: 2024年8月19日

适应症

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研究类型: Interventional
分配方式: N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Treatment

•1. Patients with epithelial tumors of the head and neck, confirmed by histopathology.
•2.Evaluated in stages III or IV (advanced locoregional disease, non-operable).
•3. That they have not previously received any oncoespecific treatment for the C and C lesion and that they are taxed on radiochemotherapy at the time of inclusion.
•4. Patients with measurable lesions, defined as those that can be accurately measured in at least one dimension (refers to the largest diameter) and have a diameter =20 mm using conventional techniques (PET, CT, NMR, Rx) Or =10 mm using spiral CT.
•5. Age =18 years.
•6. Overall state according to ECOG ?2 (Karnofsky greater than 60%).
•7. Life expectancy ?6 months.
•8. Patients who have normal functioning of organs and bone marrow defined by the following parameters:
•Leukocytes =3000/ L
•Absolute neutrophil count = to 1500/L
•Platelet count = 100,000/L
•Total bilirubin: Within normal limits
•TGP and TGO =2.5 times the institutional upper normal limit
•Creatinine: Within normal limits
•9. Female patients of childbearing potential should have a negative pregnancy test and should use appropriate contraceptive methods such as intrauterine devices, hormonal contraceptives, barrier methods or tubal ligation.
•10. Patients who have signed informed consent

•1. Pregnant or lactating women.
•2. Patients of childbearing potential who are not using an adequate method of contraception.
•3. Patients who are receiving another drug under investigation.
•4. Patients with a history of allergy to compounds of chemical or biological composition similar to nimotuzumab.
•5. Patients treated with MAB egor / 3.
•6. Patients unable to sign informed consent due to psychiatric problems or other medical problems.
•7. Patients with uncontrolled intercurrent diseases including active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, and psychiatric illness.
•8. Patients with previous neoplasias. May include those patients who have received adequate treatment for carcinomas of the skin or carcinoma in situ of the uterus.

发起方

Center of Molecular Immunology (CIM)