NCT05004831招募中2 期
Phase II Study of Fruquintinib Combined With TAS-102 in the Treatment of Patients With Advanced Metastatic CRC
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2022年3月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
This phase II study aims to explore the efficacy and safety of fruquintinib combined with TAS-102 in the third-line treatment of patients with advanced metastatic colorectal cancer.
详细描述
This is a prospective, single center, one-arm phase II study. A total of 54 advanced mCRC patients refractory to standard therapies will be enrolled and administered with fruquintinib (4mg/d, qd po, D1-21, Q4W) combined with TAS-102 (70mg/m2/d, bid po, D1-5, 8-12, Q4W) until intolerable toxicity, disease progression or death. Primary endpoint of this study is PFS and secondary endpoints are OS, ORR, DCR and safety.
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;
- •Histological or cytological confirmed advanced metastatic colorectal cancer;
- •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);
- •Signed and dated informed consent;
- •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 TAS-102;
- •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
fruquintinib plus TAS-102
Experimental
fruquintinib plus TAS-102, orally given, Q4W
干预措施: fruquintinib plus TAS-102 (Drug)
结局指标
主要结局
PFS
时间窗: from randomization up to progressive disease or EOT due to any cause, up to 2 years
Progression-free Survival
次要结局
- Safety and tolerance(from first dose to within 30 days after the last dose)
- DCR(from randomization up to progressive disease or EOT due to any cause, up to 2 years)
- ORR(from randomization up to progressive disease or EOT due to any cause, up to 2 years)
- OS(from randomization until death due to any cause, assessed up to 3 years)
研究者
Peng Jian-jun
Professor
Sun Yat-sen University
研究点 (1)
Loading locations...
相似试验
Unknown
1 期
Fruquintinib Plus Capecitabine as Maintenance Treatment of RAS / BRAF Wild-type Metastatic Colorectal CancerMetastatic Colorectal CancerNCT05016869Chinese Academy of Medical Sciences48
进行中（未招募）
2 期
Conversion Therapy of Fruquintinib in Combination With Sintilimab and SOX in Unresectable Gastric CancerGastric CancerNCT05177068Henan Cancer Hospital42
招募中
2 期
Neoadjuvant Therapy for Locally Advanced Rectal Cancer With Fruquintinib, Toripalimab and SRTRectal CancerNCT05763927West China Hospital44
尚未招募
2 期
A Prospective, Open-label, Single-arm Phase II Clinical Study of Fruquintinib Combined With S-1 for the Treatment of Metastatic Colorectal Cancer.Colorectal CancerNCT0674654530
Unknown
2 期
The First Line Treatment of Fruquintinib Combined With Albumin Paclitaxel and Gemcitabine in Pancreatic Cancer PatientsPancreatic CancerNCT05168527Fudan University30