NCT06255379尚未招募2 期
An Open, Single-arm, Multicenter, Prospective Phase II Study of Fuquinitinib Combined With Tegafur Gimeracil Oteracil in the Third-line Treatment of Patients With Advanced Metastatic CRC
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
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This is an Open, Single-arm, Multicenter, Prospective Phase II Study of Fuquinitinib Combined With Tegafur Gimeracil Oteracil in the Third-line Treatment of Patients With Advanced Metastatic CRC
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
- •≥ 18 and ≤ 75 years of age;
- •Have fully understood and voluntarily sign the ICF for this study (the icf must be signed before any trial-specific procedures are performed);Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure;
- •Histologically and/or cytologically documented metastatic colorectal adenocarcinoma;
- •Refractory to at least second line standard treatment containing fluorouracil, oxaliplatin and irinotecan;
- •At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan or 20mm by conventional CT scan);
- •ECOG performance status of 0-1;
- •Life expectancy ≥ 12 weeks;
- •No previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitor (TKI);
- •Adequate hepatic, renal, heart, and hematologic functions;
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
排除标准
- •Pregnant or lactating women;
- •Any factors that influence the usage of oral administration or any disease or condition that affects drug absorption;
- •Previous treatment with Tegafur Gimeracil Oteracil ;
- •Participated in clinical trials of other drugs within four weeks before enrollment;
- •Received other systemic anti-tumor therapy within 4 weeks before enrollment, including chemotherapy, signal transduction inhibitors, hormone therapy and immunotherapy;
- •International normalized ratio (INR) > 1.5 or partially activated prothrombin time (APTT) > 1.5 × ULN;
- •Clinically significant electrolyte abnormalities;
- •Subjected with hypertension that cannot be controlled by drugs, which is specified as: systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg;
- •Unrelieved toxic reactions higher than CTCAE V5.0 grade 1 caused by any previous anti-cancer treatment;
- •Incomplete healing of skin wound, surgical site, traumatic site, severe mucosal ulcer or fracture;
- •Conditions that may cause gastrointestinal bleeding and perforation determined by the researcher;
- •History of arterial thrombosis or deep venous thrombosis within 6 months before enrollment;
- •Stroke and / or transient cerebral ischemia occurred within 12 months before enrollment;
- •Cardiovascular diseases with significant clinical significance;
- •Congestive heart failure New York Heart Association (NYHA) grade > 2;
- •Evidence of CNS metastasis;
- •Previous treatment with VEGFR inhibition;
- •Ventricular arrhythmias requiring drug treatment;
- •Proteinuria ≥ 2+ (1.0g/24hr);
- •Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy;
- •Other malignant tumors in the past 5 years, except skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;
- •Active infection that is not controlled clinically, such as acute pneumonia, active hepatitis B or hepatitis C;
- •By judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study.
研究组 & 干预措施
Fuquinitinib +Tegafur Gimeracil Oteracil
Experimental
干预措施: Fuquinitinib+Tegafur Gimeracil Oteracil (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: from randomization up to progressive disease or EOT due to any cause, up to 2 years
PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator
次要结局
- adverse events (AE)(from day 1 of first dosing to 30days after permanent discontinuation of fruquintinib)
- Disease control rate(DCR)(from randomization up to progressive disease or EOT due to any cause, up to 2 years)
- Overall survival (OS)(from randomization up to progressive disease or EOT due to any cause, up to 3 years)
- Objective response rate(ORR)(from randomization up to progressive disease or EOT due to any cause, up to 2 years)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Fruquintinib Combined With TAS102 for Advanced Gastric CancerGastric CancerNCT06102785Tianjin Medical University Cancer Institute and Hospital30
Unknown
2 期
The First Line Treatment of Fruquintinib Combined With Albumin Paclitaxel and Gemcitabine in Pancreatic Cancer PatientsPancreatic CancerNCT05168527Fudan University30
Unknown
2 期
A Study of Famitinib in Combination With HS-10296 in Patients With EGFR-mutant NSCLCEGFR-mutant Non-Small Cell Lung CancerNCT03904823Jiangsu HengRui Medicine Co., Ltd.58
进行中（未招募）
2 期
Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid TumorsLocally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal CancerEsophageal AdenocarcinomaEsophageal Squamous Cell CancerSiewert Type 1 GEJ CancerPancreatic CancerNCT05945823Taiho Oncology, Inc.53
招募中
2 期
Neoadjuvant Therapy for Locally Advanced Rectal Cancer With Fruquintinib, Toripalimab and SRTRectal CancerNCT05763927West China Hospital44