NCT04866108Unknown2 期
A Single Center, Open-labeled, Single Arm Phase II Study of Fruquintinib Combined With Capecitabine as First-line Treatment for Advanced Metastatic Colorectal Cancer Unsuitable for Intravenous Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This is a single center, open-labeled, single arm phase II study aimed to investigate the efficacy and safety of fruquintinib combined with capecitabine as first-line treatment for advanced metastatic colorectal cancer patients unsuitable for intravenous chemotherapy.
详细描述
Fruquintinib is an oral small molecule inhibitor of VEGFR1/2/3, this phase II study aimed to investigate the efficacy and safety of fruquintinib combined with capecitabine as first-line treatment for advanced metastatic colorectal cancer patients of elderly or those unsuitable for intravenous chemotherapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old at the time of signing the informed consent;
- •Histologically or cytologically confirmed unresectable metastatic colorectal cancer;
- •Haven't received systematic therapy after diagnosis of metastatic colorectal cancer;
- •Intolerable to standard treatment of oxaliplatin- or irinotecan-based intravenous combination therapy;
- •At least one measurable lesion(s);
- •ECOG PS 0-2;
- •Life expectancy≥3 months;
- •Adequate organ and bone marrow functions;
- •Women of childbearing age must have a negative pregnancy test within the first day of the study, and contraceptive methods should be taken during the study until 6 months after the last administration;
- •Willingness and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
排除标准
- •Previous treatment with VEGFR inhibition;
- •Participating in other drug clinical trials within 4 weeks before recruited;
- •Have received other systemic anti-tumor therapies within 4 weeks before recruited;
- •Non-controlled hypertension after monotherapy, that is, systolic blood pressure > 140mmHg or diastolic blood pressure > 90mmHg;
- •Proteinuria ≥ 2+ (1.0g/24hr);
- •Clinically significant electrolyte abnormality;
- •Clinically significant cardiovascular diseases;
- •Thromboembolism or arteriovenous events occurred 6 months before recruited;
- •≥grade 3 bleeding events 4 weeks before recruited;
- •Evidence of CNS metastasis;
- •Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in GI;
- •Active, symptomatic interstitial lung disease causing dyspnea (≥ grade 2 dyspnea), pleural effusion or ascites;
- •History of organ transplantation;
- •APTT >1.5×ULN or INR>1.5;
- •History of HIV infection or active hepatitis B / C;
- •Allergic to fruquintinib and / or capecitabine;
- •Pregnant or lactating women;
- •Clinically detectable secondary primary malignancies at the time of enrollment (excluding fully treated basal cell carcinoma of the skin or carcinoma in situ of the cervix);
- •Patients who are not suitable for the study judged by the researchers.
研究组 & 干预措施
Experimental
Experimental
Fruquintinib, 4mg/d, qd po, 2 weeks on, 1 week off; Capecitabine: 825mg/m2, bid po, 2 weeks on, 1 week off
干预措施: fruquintinib plus capecitabine (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: From Baseline to primary completion date, about 3 years
ORR according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1
次要结局
- Overall Survival (OS)(From Baseline to primary completion date, about 3 years)
- Progression Free Survival (PFS)(From Baseline to primary completion date, about 3 years)
- Disease Control Rate (DCR)(From Baseline to primary completion date, about 3 years)
- Adverse Events and Serious Adverse Events(From Baseline to primary completion date, about 3 years)
- Quality of Life (QoL)(From Baseline to primary completion date, about 3 years)
研究者
Bai Zhigang
Professor
Beijing Friendship Hospital
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Xeloxiri as First-line Treatment in Patients With Advanced Unresectable Pancreatic AdenocarcinomaPancreatic AdenocarcinomaNCT01558869The University of Hong Kong37
已完成
2 期
Study of Xeloxiri Regimen for Patients With Refractory Metastatic Colorectal CancerColorectal CancerNCT03146377The University of Hong Kong32
尚未招募
2 期
A Phase II Study of Rulonilimab Combined With Chemotherapy in the First-Line Treatment for Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)PD-1Non-small Cell Lung CancerNSCLCNCT05741021Shandong New Time Pharmaceutical Co., LTD84
Unknown
2 期
A Phase II Study to Evaluate the Efficacy and Safety of F520 Combined With F007 in Patients With RR DLBCLRR DLBCL; PD-1; CD20NCT05178836Shandong New Time Pharmaceutical Co., LTD62
进行中（未招募）
2 期
Surufatinib Combined With Sintilimab and AG in First-line Therapy of Patients With Locally Advanced or Metastatic Pancreatic CancerPancreatic NeoplasmsNCT05481476Sun Yat-sen University32