NCT05747716尚未招募2 期
SBRT Combined With Fruquintinib Plus PD-1/CTLA-4 Antibody Cadonilimab for Third-line Treatment in Metastatic Colonrectal Cancer.
Wuhan Union Hospital, China1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2023年2月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
The study is a phase II clinical study. The purpose of the study is to evaluate the efficacy and safety of SBRT combined with Fruquintinib Plus PD-1/CTLA-4 Antibody for Third-line Treatment in mCRC.
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
- •Patients must have biopsy proven unresectable MCRC.
- •Patients must have received first-line and second-line chemotherapy, and approved a progressive disease.
- •Age ≥ 18 years
- •Patients must have measurable disease at baseline.
- •Patients can have up to only 5 discrete active extracranial lesions (≤3 in the liver and ≤3 in the lung) identified by position-emission tomography (PET) scan and also seen on correlative plain film, CT scan, or MRI within 8 weeks prior to the initiation of radiotherapy.
- •Patients who previously received radiotherapy to the primary site will be ineligible if there is CT evidence of disease progression within the past 3 months.
- •Patients must have a Karnofsky Performance Scores (KPS) >60
- •Aspartate aminotransferase, alanine aminotransferase & Alkaline phosphates must be ≤ 2.5 times the upper limit of normal (ULN). Total bilirubin must be within the limit of normal.
- •Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm
- •Patients should have adequate renal function (serum creatinine ≤1.5 times the ULN).
- •Females of childbearing potential should have a negative pregnancy test.
- •Patients who would be receiving radiation for lung lesions who are known or suspected by the treating radiation oncologist to have compromised lung function must have a documented forced expiratory volume in 1 second (FEV1) ≥ 1 litre.
- •Patients must provide verbal and written informed consent to participate in the study.
- •Total bilirubin: within normal institutional limits
排除标准
- •Patients with either untreated brain metastases or brain metastases treated within the past three months are ineligible
- •Patients with serious, uncontrolled, concurrent infection(s).
- •Significant weight loss (>10%) in the prior 3 months.
- •Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cancers.
- •Patients with more than 5 discrete metastatic lesions.
- •Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
- •Unwillingness to participate or inability to comply with the protocol for the duration of the study.
- •Patients who are pregnant. Patients with reproductive capability will need to use adequate contraception during the time of participation in the study
研究组 & 干预措施
SBRT, Fruquintinib, Cadonilimab
Experimental
干预措施: SBRT, Fruquintinib, Cadonilimab (Drug)
结局指标
主要结局
Progression free survival
时间窗: 2 years
Progression free survival
次要结局
- Actuarial rate in-field local control(2 years)
- Toxicities(2 years)
研究者
研究点 (1)
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