RPCEC00000237尚未招募1 期
Safety, immunogenicity and evidence of effect of vaccine candidate CIGB-247 in the treatment of hepatocellular carcinoma.
Center for Genetic Engineering and Biotechnology (CIGB), in Havana.0 个研究点目标入组 20 人开始时间: 2017年2月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial. Masking: Open. Control group: Uncontrolled. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 70 years（—）
- 性别
- All
入选标准
- •1) Compliance with diagnostic criteria (established by histological study or non-invasive criteria for the diagnosis of hepatocellular carcinoma in cirrhotic patients or with hepatitis B virus presenting liver lesions greater than 1 cm tumor: Injury greater than or equal to 1 Cm detected by multislice computed tomography or dynamic contrast-enhanced nuclear magnetic resonance, which shows arterial hypervascularization and late portal or portal phase lavage).
- •2) Age between 18 - 70 years, both inclusive.
- •3) Patients in stages B or C, according to BCLC (Barcelona Clinic Liver Cancer) staging.
- •a) Patient with a life expectancy = 6 months.
- •b) Functional state according to ECOG = 2.
- •4) Patient with at least one measurable lesion, according to modified RECIST criteria (mRECIST), and RECIL (Response Evaluation Criteria in Cancer of the Liver).
- •5) Patient with stabilization or progressive disease at the time of inclusion in the study.
- •6) Voluntariness of the patient through the signing of informed consent.
排除标准
- •1) Unknown primary tumor.
- •2) Patients who have received antiangiogenic treatment in the last three months.
- •3) Have received chemoradiotherapy in the last 4 weeks.
- •4) Major surgery in the last 28 days.
- •5) Referred immunosuppressive disease; Ingestion of immunosuppressive / immunomodulatory drugs.
- •6) Patient with cerebral metastasis.
- •7) Decompensated chronic diseases (hypertension, diabetes mellitus, chronic renal failure, heart failure, hyperthyroidism, epilepsy).
- •8) History of autoimmune disease (systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, type 1 diabetes mellitus, etc.) and severe allergic history (urticaria, dermatitis, bronchitis and persistent bronchial asthma).
- •9) Moderate or severe systemic infections that interfere with patient assessment.
- •10) History of allergy to any ingredient in the vaccine under study.
- •11) Patient pregnant or breastfeeding.
- •12) Obvious mental inability to issue consent and act accordingly with the study.
研究者
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