A Combined Phase I&II, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate Efficacy and Safety for Prevention and Treatment of Radiation Therapy Burn of CH1701
试验速览
- 阶段
- 1 期
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Side effects by skin biopsy
研究概览
简要总结
A combined Phase I&II, randomized, double-blind, placebo-controlled clinical trial to evaluate efficacy and safety for prevention and treatment of radiation therapy burn of CH1701
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants and investigator are blinded to the treatment
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers, aged 18 and older at the time of enrollment
- •Voluntarily participate in the study by signing a consent form to participate in the study
- •Ability to adhere to treatment according to researchers' assessment
排除标准
- •Subjects with other acute or chronic diseases need to be treated
- •It is not possible to comply with the research or studied drug treatment process in the opinion of the researcher
- •Phase II:
- •Inclusion Criteria:
- •Female patient, aged 18 to 60 years old
- •Having been diagnosed with breast cancer with axillary lymph node metastasis, having radiation therapy for radiation therapy in the range of 45-50 Gy for a period of 5-6 weeks
- •Treatment can be started within 3 days of signing the consent to participate in the study
- •Agree to voluntarily sign the consent form to participate in the study
- •Exclusion Criteria:
- •The available skin lesions in the breast and chest and according to the researchers' judgment will affect the assessment of inflammation caused by radiation
- •The patient had radiation therapy before the breast area
- •History of connective tissue disorders
- •The patient is incapable of complying with the research procedures or is unable to ensure compliance with the study medication as assessed by the researcher
- •Participate in other clinical trial studies within 1 month before joining this study
研究组 & 干预措施
50% dose level arm - Phase I
4 healthy volunteer will use 50% dose level for Phase I in the left hand side and use placebo in the right hand side
干预措施: Safety assessment of CH1701 (Drug)
100% dose level arm - Phase I
4 healthy volunteer will use 100% dose level for Phase I in the left hand side and use placebo in the right hand side
干预措施: Safety assessment of CH1701 (Drug)
167% dose level arm - Phase I
4 healthy volunteer will use 167% dose level for Phase I in the left hand side and use placebo in the right hand side
干预措施: Safety assessment of CH1701 (Drug)
Placebo arm - Phase II
20 Breast cancer patients will use Placebo in the radiation affected area right after radiation
干预措施: Placebos (Drug)
50% dose level arm - Phase II
20 Breast cancer patients will use CH1701 with 50% of the expected dose level in the radiation affected area right after radiation
干预措施: CH1701 for prevention and treatment of radiation burns. (Drug)
100% dose level arm - Phase II
20 Breast cancer patients will use CH1701 with 100% of the expected dose level in the radiation affected area right after radiation
干预措施: CH1701 for prevention and treatment of radiation burns. (Drug)
167% dose level arm - Phase II
20 Breast cancer patients will use CH1701 with 167% of the expected dose level in the radiation affected area right after radiation
干预措施: CH1701 for prevention and treatment of radiation burns. (Drug)
结局指标
主要结局
Side effects by skin biopsy
时间窗: 14 days
Skin biopsy after 14 days of topical application, compared with healthy skin
Degree of burns according to CTCAE 4.03 atlas
时间窗: 63 days
Take photograph of skin every week comparing with atlas CTCAE 4.03 to determine the degree of burns
次要结局
未报告次要终点