JPRN-jRCTs031210544进行中（未招募）3 期
JCOG2014: Randomized phase III study of bi-weekly trifluridine/tipiracil plus bevacizumab vs trifluridine/tipiracil alone for chemorefractory metastatic colorectal cancer - ROBiTS
YAMAZAKI Kentaro0 个研究点目标入组 420 人开始时间: 2022年1月11日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 420
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1) Pathologically proven colorectal adenocarcinoma
- •(2) Tumor located between cecum and lower rectum (caecum [C], asending colon [A], transverse colon [T], descending colon [D], sigmoid colon [S], rectosigmoid [RS], upper rectum [Ra], lower rectum [Rb])
- •(3) Unresectable StageIV or recurrent colorectal cancer diagnosed by enhanced chest/abdominal/pelvic computed tomography
- •(4) Known RAS status
- •(5) Known BRAFV600E status
- •(6) Age>=20 years
- •(7) ECOG PS 0 or 1
- •(8) Measurable lesions based on the RECIST v1.1
- •(9) Refractory or intolerant to fluoropyrimidine, oxaliplatin, irinotecan, anti-VEGF therapy, anti-EGFR therapy (for tumors with wild-type RAS), BRAF inhibitor plus anti-EGFR combination (for tumors with mutant-type BRAFV600E), and immune checkpoint inhibitors (for tumors with MSI-H)
- •(10) No prior FTD/TPI therapy
- •(11) Able to take oral drugs
- •(12) No surgical history within 28 days prior to registration
- •(13) Adequate organ function within 7days prior to registration (neutrophil count>=1,200/mm3, hemoglobin>=8.0g/dL, platelet count>=75,000/mm3, total bilirubin<=1.5mg/dL, serum transaminases<=100U/L [<=200U/L for liver metastases], serum creatinine<=1.5mg/dL, urine protein<=1+ or UPCR<=2.0)
- •(14))With written informed consent
排除标准
- •(1) Synchronous or metachronous active malignancies other than colorectal cancer (within 2 years)
- •(2) Infectious disease requiring systemic treatment
- •(3) Fever above 38 degree Celsius
- •(4) Women who are pregnant, breast feeding, or who wish to conceive. Men who wish to conceive.
- •(5) Severe psychological disease
- •(6) Continuous systemic corticosteroid or immunosuppressants
- •(7) Uncontrolled hypertension
- •(8) History of new or worsened unstable angina within 3 weeks
- •(9) Uncontrolled valvular heart disease, dilated cardiomyopathy or hypertrophic cardiomyopathy
- •(10) HCV antibody positive
- •(11) Active or persistent bleeding
- •(12) Metastasis to central nerve system
- •(13) Ascites, pleural effusion, or pericardial effusion with drainage within 4 weeks
- •(14) Chronic lung disease requiring oxygen administration
- •(15) Unrecovered grade 2 or higer (CTCAE ver.5.0) AEs related to previous treatment
- •(16) Unstable thromboembolism
研究者
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