A Study on the Efficacy and Safety of Multi-mode Ablation Combined With Systemic Therapy Including PD-1 Inhibitor in the Treatment of Colorectal Cancer Liver Metastasis(CRCLM)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The goal of this study is to evaluate the efficacy and safety of multi-mode ablation combined with systemic therapy including PD-1(programmed death receptor 1) inhibitor for colorectal cancer liver metastasis and furthermore to clarify its application value by comparing preoperative and postoperative immune indicators.
详细描述
This is a single-center, single-arm, prospective study to evaluate the efficacy and safety of multi-mode ablation combined with systemic therapy including PD-1 inhibitor in the treatment of colorectal cancer liver metastasis. The study includes 20 patients with colorectal cancer liver metastasis that has failed first-line therapy and is unresectable. All patients will receive multi-mode ablation to achieve complete remission of liver lesions followed by systemic therapy including PD-1 inhibitor.
This study will provide preliminary data on the efficacy and safety of multi-mode ablation combined with systemic therapy including PD-1 inhibitor in the treatment of colorectal cancer liver metastasis, which could lead to larger randomized trials.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years, gender not specified;
- •Pathologically or clinically confirmed colorectal cancer liver metastases, with liver lesions unsuitable for surgical resection or intolerance or refusal of surgical resection;
- •In the case of an unresectable primary tumor or recurrence, the absence of serious complications such as bleeding or obstruction;
- •Failure of first-line treatment, with disease progression or new liver metastases;
- •No more than 5 liver lesions, with single lesion diameter ≤ 3cm;
- •For those who have received previous chemotherapy, radiotherapy or local liver treatment, the interval from the last systemic treatment or local liver treatment should be at least 1 month;
- •Child-Pugh A or B; bilirubin ≤ 3.0 mg/dL, creatinine ≤ 2.5 mg/dL, white blood cell count ≥ 2.0 ×10^9/L, platelets ≥ 100 ×10^9/L;
- •ECOG PS ≤ 2;
- •Willing to accept subsequent treatment regimens that include anti-PD-1 monoclonal antibody therapy.
排除标准
- •Liver function Child-Pugh class C;
- •Expected survival < 3 months;
- •Major organ insufficiency or failure;
- •Active infection;
- •Irreversible coagulation disorders;
- •Refractory massive ascites, pleural effusion or cachexia;
- •Unable to cooperate with treatment;
- •Any other factors deemed inappropriate for inclusion or that may affect the subject's participation in the study, as determined by the investigator.
研究组 & 干预措施
Multi-mode thermal ablation combined with systemic therapy including PD-1 inhibitor
Multi-mode ablation therapy +systemic therapy including PD-1 inhibitor (sintilimab 200 mg IV D1+ mFOLFOX6 or FOLFIRI+bevacizumab or cetuximab（determined according to the subject's first-line chemotherapy regimen), Q3W, chemotherapy for 4-6 cycles. Sintilimab continues until disease progression, not exceeding a maximum of 2 years.)
干预措施: Multi-mode tumor treatment system (Device)
Multi-mode thermal ablation combined with systemic therapy including PD-1 inhibitor
Multi-mode ablation therapy +systemic therapy including PD-1 inhibitor (sintilimab 200 mg IV D1+ mFOLFOX6 or FOLFIRI+bevacizumab or cetuximab（determined according to the subject's first-line chemotherapy regimen), Q3W, chemotherapy for 4-6 cycles. Sintilimab continues until disease progression, not exceeding a maximum of 2 years.)
干预措施: Sintilimab+mFOLFOX6 or FOLFIRI+bevacizumab or cetuximab (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: max 24 months
Progression free survival (PFS) is defined as the time from the start of treatment until the criteria for documented progression of disease (or until death due to any cause) are met, whichever comes first according to RECIST 1.1.
次要结局
- Local Progression Free Survival (LPFS)(max 24 months)
- Objective Response Rate (ORR)(max 24 months)
- Overall Survival (OS)(max 24 months)
- Rate of adverse events(max 24 months)
- Immune indicator analysis(max 24 months)
研究者
Shen Zan
Chief of Medical Oncology
Shanghai 6th People's Hospital