NCT06485713招募中2 期
Efficacy and Safety of Trifluridine/Tipiracil Combined With Fufuquitinib Versus Trifluridine/Tipiracil and Fufuquitinib for Third-line Treatment of Unresectable Metastatic Colorectal Cancer
First Affiliated Hospital of Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年3月1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
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
To evaluate the efficacy and safety of trifluridine/tipiracil combined with fufuquitinib versus trifluridine/tipiracil and fufuquitinib in patients with unresectable metastatic colorectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •1.Age 18-75 (at the time of signing the informed consent);ECOG PS score: 0-1; Expected survival time > 3 months.
- •2.Patients with advanced colorectal adenocarcinoma confirmed by histopathology who had failed standard first - and second-line treatment.
- •3.At least 1 measurable lesion was present according to RECIST1.1 criteria. 4.Good organ function, laboratory tests meet the following criteria:
- •Hemoglobin ≥90g/L;Absolute count of neutrophils (ANC) ≥1.5×109/L;Platelet ≥100×109/L;
- •ALT and AST≤2.5 upper limit of normal (ULN).ALP≤2.5 ULN;(if liver metastases ≤5 ULN);
- •Total bilirubin (TBIL) < 1.5 ULN;
- •Serum creatinine (CR) <1.5 ULN or creatinine clearance (CCR) ≥50ml/min;
- •Serum albumin ≥30g/L;
- •International Normalized ratio (INR), prothrombin time (PT), activated partial thrombin time (APTT) ≤1.5ULN;
- •Thyrotropin (TSH) ≤ULN;If abnormal, T3 and T4 levels should be investigated, and normal levels can be included.
- •5.cardiac color ultrasound: Left ventricular ejection fraction (LVEF) ≥50%. 6.Hypertension was well controlled. 7.Female participants of reproductive age should agree to use contraception during the study period and for 6 months after the study ends; Serum pregnancy test was negative within 7 days prior to study enrollment,and should be Non-lactation stage. Male subjects should agree to use contraception during the study period and for 6 months after the study ends.
排除标准
- •1.Combined disease or history
- •.Present or present with other malignancies within 3 years.
- •.Have multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea, or intestinal obstruction)
- •.Gastrointestinal bleeding or perforation occurred during the first 4 weeks of enrollment
- •.Patients with ulcerative colitis, Crohn's disease, and active inflammatory bowel disease during the first 4 weeks of enrollment
- •.Uncontrolled pleural effusion, ascites, and moderate or greater pericardial effusion
- •.Unmitigated toxic reactions above grade 1 of CTC AE due to any previous treatment, excluding alopecia.
- •.Received major surgical treatment or significant traumatic injury within 28 days prior to enrollment
- •.Patients with hematemesis, hematochezia, or any bleeding event ≥ CTCS AE level 3 within the previous 3 months, or with any signs of bleeding or history determined by the investigator to be ineligible for enrollment
- •.Arteriovenous thrombosis occurred within 6 months, such as cerebrovascular accident, pulmonary embolism, etc
- •.A history of psychotropic substance abuse and inability to abstain
- •.Subjects with any severe and/or uncontrolled disease, including
- •Uncontrolled hypertension
- •Unstable angina pectoris / ≥ grade 2 cardiogenic chest pain;Myocardial infarction occurred within 12 months before randomization;≥ grade 2 heart failure;Restrictive heart disease;≥ grade 2 atrioventricular block, arrhythmia that cannot be stably controlled with drugs.
- •Active infection
- •Decompensated cirrhosis, active hepatitis;
- •Renal failure requires hemodialysis or peritoneal dialysis
- •A history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation
- •h.Diabetes with poorly controlled i.Urine routine showed urine protein ≥++, and 24h albuminuria quantitative > 1.0 g g.History of neurological or psychiatric disorders 2.Subjects who, in the investigator's judgment, have a concomitant medical condition that seriously endangers subjects' safety or interferes with the completion of the study, or are deemed unsuitable for enrollment for other reasons.
研究组 & 干预措施
Experimental group
Experimental
trifluridine/tipiracil combined with fufuquitinib
干预措施: trifluridine/tipiracil combined with fufuquitinib (Drug)
Control Group 1
Active Comparator
Fufuquitinib
干预措施: fufuquitinib (Drug)
Control Group 2
Active Comparator
Trifluridine/tipiracil
干预措施: Trifluridine/tipiracil (Drug)
结局指标
主要结局
Progression-free survival
时间窗: up to 24 weeks
次要结局
- Total survival time(up to 2 years)
研究者
研究点 (1)
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