An Open, Single Center Clinical Study Based on DarwinOncoTreatTM (DOTr) and DarwinOncoTargetTM (DOTa) Algorithm Guidance for Treating Solid Tumor Patients Who Are Exhausted or Unable to Tolerate Standard Treatment Regimens
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Feasibility of selecting treatment plans based on DOTr/DOTA result
研究概览
简要总结
This study is an open, single center clinical study targeting solid tumor patients who have exhausted or cannot tolerate standard treatment regimens. The main purpose of this study is to investigate the feasibility, efficacy, and safety of selecting treatment regimens based on DOTr/DOTa results for solid tumor patients who have exhausted or cannot tolerate standard treatment regimens.
详细描述
Both OncoTarget(DarwinOncoTargetTM (DOTa)), which identifies high-affinity inhibitors of individual master regulator (MR) proteins, and OncoTreat(DarwinOncoTreatTM (DOTr)), which identifies drugs that invert the transcriptional activity of hyperconnected MR modules, produced highly significant 30-day disease control rates (68% and 91%, respectively).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subjects must be able to understand the procedures and methods of this study, be willing to strictly follow the clinical trial protocol to complete this trial, and voluntarily sign a written informed consent form;
- •Patients aged ≥ 18 years old;
- •Solid tumor patients who are depleted of standard treatment or unable to tolerate standard treatment regimens;
- •According to the RECIST solid tumor efficacy evaluation criteria, there should be at least one measurable lesion;
- •ECOG PS score 0-4 (3-4 score only for patients caused by tumor);
- •The expected survival period is not less than 12 weeks;
- •Women of childbearing age must have a Pregnancy test (serum) within 7 days before enrollment, and the result is negative, and are willing to use appropriate methods of contraception during the test period and within 8 weeks after the last administration of the test drug;
- •The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up;
- •If the main organs function normally, they meet the following standards:
- •The blood routine examination standard must comply with (no blood transfusion or blood products within 14 days, no correction using G-CSF or other hematopoietic stimulating factors): Hb ≥ 90g/L; ANC ≥ 1.5 × 109/L; PLT ≥ 90 × 109/L;Biochemical examination must meet the following standards: TBIL ≤ 1 × ULN; ALT, AST ≤ 1.5 × ULN; ALP ≤ 2.5 × ULN; BUN and Cr ≤ 1.5 × ULN; Color Doppler echocardiography: left ventricular Ejection fraction (LVEF) ≥ 50%.
排除标准
- •Severe heart disease or discomfort that cannot be treated;
- •Those who suffer from mental illness or abuse of psychotropic substances and are unable to cooperate;
- •Pregnant or lactating female patients;
- •Participating in other clinical trials at the same time;
- •Researchers believe that individuals are not suitable for enrollment.
结局指标
主要结局
Feasibility of selecting treatment plans based on DOTr/DOTA result
时间窗: Through study completion, an expected average of 2year
The proportion of patients who successfully develop treatment plans based on DOTr and DOTa test
次要结局
- AEs(Through study completion, an expected average of 1 year)
- ORR(Through study completion, an expected average of 1 year)
- PFS2/PFS1(Through study completion, an expected average of 1 year)