Intratumoral application of CIGB 300 concomitant to chemo radiotherapy in patients with stage IB2 and II cervical cancer.

Center for Genetic Engineering and Biotechnology (CIGB), in Havana0 个研究点目标入组 144 人开始时间: 2018年8月7日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment

•1) Patients that meet the histological diagnostic criteria of squamous cell carcinoma or adenocarcinoma, stage IB2-II.
•2) Patients with ECOG 0-1.
•3) Informed consent signed by the patient.
•4) Patients with normal hepatic, renal and hematological functions.

•1) Pregnancy and lactation.
•2) Patients included in another clinical trial and who have received any biological therapy in research, including active or passive immunotherapy in the last 6 months.
•3) Chronic decompensated diseases (hypertension, diabetes mellitus, chronic renal failure, heart failure, hyperthyroidism, malignant neoplasms, epilepsy, severe mental depression).
•4) Allergic diseases (example, persistent bronchial asthma).
•5) Acute infectious disease that prevents the application of the research product.
•6) Diseases that compromise the patient's state of consciousness or their ability to give informed consent or collaborate in the trial.
•7) Extensive tumor necrosis or endophytic tumor that prevents the application of the product as provided in this protocol.
•8) Conditions that prevent the realization of high-field magnetic resonance imaging: cardiac pacemaker, implantable cardiac defibrillator; cochlear implant, vascular, metallic clips, vascular prosthesis, vascular stent, IUD, orthopedic prostheses, fragments of metals in the body (like projectiles of firearm), tattoos.
•9) Use of intrauterine devices (IUDs), which contain copper.
•10) Patients with claustrophobia (assess study under sedation).
•11) Obese patients that exceed the limit of the gantry (tube) of the resonator.

发起方

Center for Genetic Engineering and Biotechnology (CIGB), in Havana