Patients With Advanced Refractory Solid Tumors Who Failed Standard Treatments and Matched Individualized Treatment Based on Tumor Molecular Characteristics: a Prospective Registration Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This is a prospective registration study for patients with advanced refractory solid tumors. Patients who meet the eligibility criteria will be included to participate in the study, and baseline information to be collected after signed informed consent. Patients will choose for themselves whether to carry out targeted therapy or other appropriate treatment methods. And we plan to follow up for at least 12 months or until disease progression or death.
详细描述
- Screen and enroll 120 patients with refractory solid tumors, and sign informed consents;
- Extract the clinical data, including gender, age, disease diagnosis, past treatment history and genetic test results, etc.;
- Take biopsy samples and perform NGS testing on patients. After discussion by the Molecular Steering Committee (MTB), the recommendations for treatment guidance will be given based on treatment guidelines and clinical experience;
- The patient and the clinician jointly select the treatment plan and follow-up until the patient's disease progresses. The follow-up time will be 1 year;
- During the follow-up period, clinical treatment and routine examination information of patients will be collected;
- If the patient fails to receive molecular targeted therapy or they cannot tolerate the adverse reaction of the drug after adequate treatment, the clinician will evaluate whether a second NGS resistance test is needed or the participant may withdraw from the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Recurrent or metastatic malignant solid tumor confirmed by histology or cytology
- •Disease progression or intolerance after receiving standard treatment
- •With evaluable lesions (RECIST 1.1 standard)
- •Tumor tissue pieces with sufficient formalin-fixed paraffin-embedded (FFPE) can be used for genetic testing
- •ECOG PS score 0-4 (3-4 points only for patients with tumor burden)
- •Sign the informed consent form
排除标准
- •The subject is participating in any other clinical research;
- •Researchers believe that serious or uncontrolled medical diseases (ie uncontrolled diabetes, chronic kidney disease, chronic lung disease, or uncontrolled active infections, mental illnesses/social conditions that restrict compliance with research requirements) that will confuse the analysis of research treatment response ；
- •Patients during pregnancy or lactation
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 2021.11-2023.11
ORR is judged based on RECIST 1.1 criteria for all treatment groups at each visit period.
Proportion of targeted therapy guided by tumor molecular characteristics
时间窗: 2021.11-2023.11
The proportion of all enrolled patients receiving targeted therapy guided by tumor molecular characteristics during the study period, would be calculated, which defined as having received one or more the treatments based on tumor molecular characteristics.
次要结局
- Progression-free survival (PFS)(2021.11-2023.11)
- Overall survival (OS)(2021.11-2023.11)
- Adverse events(2021.11-2023.11)
- Proportion of patients with intervening genomic variants(2021.11-2023.11)
- Best overall response (BOR)(2021.11-2023.11)
- Quality of Life Score (QoL)(2021.11-2023.11)