NCT03474861Unknown1 期
A Combination Study to Evaluate the Safety and Efficacy of an Anticancer Medication (A01) With Immune Cells (IC01) in Subjects With Advanced Gastrointestinal Cancer
Hangzhou Converd Co., Ltd.0 个研究点目标入组 15 人开始时间: 2018年4月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 15
- 主要终点
- The adverse events associated with infusion of the anticancer medication or the immune cells will be assessed.
研究概览
简要总结
This is an open-label study to evaluate the safety and efficacy of an anticancer medication (A01) combined with immune cells (IC01) in subjects with advanced Gastrointestinal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form must be obtained prior to any research procedures;
- •Age: 18 Years to 70 Years;
- •The patient's biological parent or child whose age ≥18 years voluntarily donates peripheral blood (200 ml) for the treatment, and who signs the informed consent form independently;
- •Histologically confirmed diagnosis of gastrointestinal cancer;
- •Patients who have received at least one standard treatment (surgery, chemotherapy, radiotherapy, or targeted therapy) or refuse to receive standard treatments;
- •Karnofsky Performance Status (KPS) score ≥ 70
- •Expected survival ≥ 3 months
- •Adequate organ function defined as: ANC≥3.5×10^9/L, PLT≥50×10^9/L, ALB≥25g/L, AST≤2.5×ULN, ALT≤2.5×ULN, TBIL≤1.5×ULN
- •If a subject is a female of childbearing potential, she must have a negative urine pregnancy test result.
排除标准
- •Patients who received chemotherapy, large-field radiotherapy or participated in other studies of anti-tumor therapy within 2 weeks before enrollment;
- •Patients who have not recovered from adverse reactions related to above-mentioned procedures;
- •Patients with two types of primary solid tumors;
- •Patients with brain metastases or bone metastases;
- •Patients with poorly controlled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 90 mmHg), or cardiovascular and cerebrovascular diseases with clinical significance, such as cerebrovascular accident (within 6 months before signing informed consent), myocardial infarction (within 6 months before signing informed consent), unstable angina, congestive heart failure (New York Heart Association Class II or above), or severe arrhythmia which can't be controlled with drugs or have potential impact on treatment;
- •Patients with other serious organic diseases or mental disorders;
- •Patients with systemic or active infection;
- •Patients with positive HIV test result;
- •Patients who have received an organ transplant;
- •Patients who are breastfeeding or pregnant.
结局指标
主要结局
The adverse events associated with infusion of the anticancer medication or the immune cells will be assessed.
时间窗: Day 0 to 4 months after the end of the trial
Incidence and duration of all the adverse events will be recorded. The severity of adverse events will be evaluated according to NCI-CTCAE v4.03 criteria.
次要结局
- Tumor Response of the treatment in patients with advanced gastrointestinal cancer.(Before treatment and Day 28 to 4 months after the end of the treatment)
研究者
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