NCT05314101Unknown2 期
TAS-102 Combined With Bevacizumab and Tislelizumab Third-line or Above in the Treatment of Liver Metastasis in Colorectal Cancer : An Open-label 、Phase Ⅱ Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- progression free survival
研究概览
简要总结
To evaluate the clinical efficacy and safety of TAS-102 combined with bevacizumab and tislelizumab in third-line or above treatment in patients with advanced colorectal adenocarcinoma with liver metastasis.
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 who provided informed consent and voluntarily enrolled
- •Patients with liver metastasis of advanced colorectal adenocarcinoma with MSS confirmed by pathology;
- •18-75 years old;
- •Measurable target lesions according to RECIST V1.1 assessment criteria;
- •Progression after standard second-line treatment (irinotecan, oxaliplatin, or fluorouracil);
- •0 ~ 2 points according to ECOG quality of life score;
- •Drugs can be taken orally
- •Estimated survival ≥3 months;
- •Women of childbearing age should comply with contraceptive measures if pregnancy test is negative;
- •Ascites with no obvious symptoms and no clinical intervention;
- •Adequate organ and bone marrow functions, ecg, blood, biochemical and other basic tests are not contraindications of chemotherapy;
- •Adherence to scheduled visits, treatment plans, laboratory tests, and other study procedures Willingness and ability.
排除标准
- •Previous application of TAS-102;
- •Pregnant or lactating women;
- •No contraception during the reproductive period;
- •patients known to have a history of allergy to any study drug, similar drug or excipient;
- •Patients with risk of massive gastrointestinal bleeding or gastrointestinal obstruction;
- •Patients with a history of thromboembolism, except those caused by PICC;
- •Patients with active infection;
- •Patients with uncontrolled hypertension (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥90) MmHg);
- •Patients with brain metastases with clinical symptoms or imaging evidence;
- •Contraindications for treatment of other chronic diseases;
- •Previous immunotherapy-related myocarditis, pneumonia, colitis, hepatitis, kidney Inflammation and other conditions, the current AE is still ≥2;
- •According to THE NCI CTCAE 5.0 assessment criteria, there are all types of existing cases due to previous treatment Patients with grade ≥2 toxic reactions;
- •Other conditions that the investigator determines are not suitable for inclusion in the study.
- •Received any anti-tumor therapy and participated in other clinical studies within 4 weeks prior to enrollment.
研究组 & 干预措施
TAS-102 combined with bevacizumab and tislelizumab
Experimental
TAS-102 combined with bevacizumab and tislelizumab third-line or above in the treatment of liver metastasis in colorectal cancer
干预措施: Tislelizumab (Drug)
TAS-102 combined with bevacizumab and tislelizumab
Experimental
TAS-102 combined with bevacizumab and tislelizumab third-line or above in the treatment of liver metastasis in colorectal cancer
干预措施: bevacizumab (Drug)
TAS-102 combined with bevacizumab and tislelizumab
Experimental
TAS-102 combined with bevacizumab and tislelizumab third-line or above in the treatment of liver metastasis in colorectal cancer
干预措施: TAS-102 (Drug)
结局指标
主要结局
progression free survival
时间窗: up to 24 months
Time from enrollment to the onset of disease progression or death.
次要结局
- Objective Response Rate (ORR)(every 8 weeks (up to 24 months))
研究者
研究点 (1)
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