Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy in ICIs Treated Primary Liver Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 5
- 主要终点
- PFS: Progression-free survival
研究概览
简要总结
To evaluate the predictive value of ctDNA in response, relapse for liver cancer patients treated with immune checkpoint inhibitors
详细描述
In the study, 300 advanced primery liver cancer patients who received immune checkpoint inhibitors at first-line setting (N=200) or second-line setting (N=100) will be recruited. By analyzing the ctDNA and peripheral blood mononuclear cell (PBMC) collected before and after the first cycle of ICI treatment, the dynamic changes of bTMB, ctDNA and the composition of immune cells will be detected. Combined with the tumor markers AFP, DCP and CA19-9, a noninvasive multiparameter model will be developed.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary liver cancer diagnosed according to the clinical diagnostic criteria, or histopathological or cytological examination;
- •18-80 years old, no limit on gender;
- •ECOG performance status of 0-2, with expected survival time of more than 12 weeks;
- •According to RECIST V1.1, there must be at least one measurable lesion;
- •Patients who are suitable for ICIs treatment and willing to comply with required protocols and give permission to use the data for clinical research and products development;
- •Patients who join the study voluntarily, sign a consent form, have good compliance, and comply with follow-up.
排除标准
- •Patients with other primary cancers;
- •Patients with a severe parenchymal disease and unable to accept ICIs treatment;
- •Patients with a psychiatric disorder and unable to comply with this study;
- •Patients with symptomatic brain metastasis, anticipated complications or cognitive disorders that are associated with brain metastasis;
- •Adverse events related to prior anti-tumor treatment (except for hair loss of any grade) did not return to grade 1 or better;
- •History of cells or organ transplantation;
- •History of hypersensitivity to the drug administered in this study or contrast media for CT and MRI;
- •Patients who accepted hepatic local therapy (including ablation therapy, percutaneous injection of ethanol or acetic acid (PEI/PAI), high-intensity focused ultrasound (HIFU), transarterial chemoembolization (TACE)) within 14 days prior to initiation of the study;
- •Other reasons that the researchers think not suitable for ICIs treatment
结局指标
主要结局
PFS: Progression-free survival
时间窗: 24 months
The time length from the date of randomization to any of the following events: disease progression or death from any cause.
次要结局
- TTD: Time to Treatment Discontinuation(24 months)
- OS: Overall Survival(24 months)
- ORR: Objective Response Rate(24 months)