RPCEC00000339尚未招募1 期
Phase I study in patients at high risk of lung cancer and early-stage lung cancer survivors treated with the therapeutic vaccine CIMAvax®
Center of Molecular Immunology (CIM)0 个研究点目标入组 60 人开始时间: 2020年10月22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
- 60
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
- N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Prevention
入排标准
- 年龄范围
- 18 years 至 79 years（—）
- 性别
- All
入选标准
- •1. Patients who meet the diagnostic criteria according to the cohort to which they belong.
- •2. Patients aged = 18 years for survivors of lung cancer and between 50 and 79 years for patients at high risk of lung cancer.
- •3. Patients who do not have imaging evidence of lung cancer, evaluated by CT according to RECIST criteria.
- •4. Patients of childbearing age who consent to the use of appropriate contraceptive methods (for example, hormonal or barrier contraceptive methods, withdrawal) before being included in the study. If a woman becomes pregnant or suspects that she is pregnant while she or her partner is participating in this study, she should inform her doctor immediately.
- •5. Patients who give their informed consent to participate in writing.
- •In addition to the above criteria, patients must meet the following specific criteria of the cohort in which they will be included:
- •Patients at high risk of lung cancer (Cohort A).
- •1. Document the presence of any of these risk factors
- •Moderate or severe COPD.
- •Family history of lung cancer.
- •Low body mass index.
- •Recent pneumonia.
- •2. Have quit smoking in the last 10 years or be a current smoker.
- •3. Have a history of smoking at least 50 packages / year.
- •4. Have the lung function test in the last 3 months before inclusion.
- •Survivors of early stage lung cancer (Cohort B).
- •1. Having completed 3 months before inclusion, adjuvant therapy for lung cancer after surgery, with no evidence of early disease progression.
- •2. CPCNP confirmed in stage IB to IIIA in the initial diagnosis (TNM 8th edition).
排除标准
- •1. Patients not clinically fit to undergo the bronchoscopy procedure.
- •2. Patients with uncontrolled intercurrent diseases that include, among others, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.
- •3. Patients with stage IIIA who are not surgical.
- •4. Patients with mild or very severe COPD.
- •5. Patients with psychiatric illness and / or social situations that would limit compliance with the study requirements.
- •6. Pregnant or breastfeeding patients.
- •7. Patients with another malignant disease in the previous 5 years, except skin cancer (not melanoma).
- •8. Patients who have received another product under investigation within 30 days prior to inclusion.
- •9. Patients who have received treatment for their disease with immunotherapy.
- •10. Patients with known immunosuppressive disease (for example, HIV, AIDS or other immunosuppressive disease). The test is not mandatory.
- •11. Patients with known hypersensitivity to the vaccine components under study or any analogue.
- •12. Patients requiring steroid treatment equivalent to doses greater than 20 mg of prednisone daily.
- •13. Patients reluctant or unable to follow the requirements of the protocol.
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