NCT06584032招募中3 期
A Randomized,Open-label,Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of Fruquintinib Plus Sintilimab Versus Chemotherapy of the Treating Physician's Choice as Second-line Treatment for Advanced Endometrial Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Hutchmed
- 入组人数
- 412
- 试验地点
- 2
- 主要终点
- Progression-Free Survival (PFS) as assessed by IRC
研究概览
简要总结
The goal of this study is to evaluate whether fruquintinib(HMPL-013) plus sintilimab(IBI308) is safe and effective in the treatment of advanced endometrial cancer(EMC).
详细描述
A randomized, open, positive-controlled, multicenter Phase III clinical study to compare the efficacy and safety of fruquintinib(HMPL-013) plus sintilimab(IBI308) versus chemotherapy in patients with advanced endometrial cancer who have progressed after first-line standard chemotherapy
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Have fully understood and voluntarily signed the informed consent form
- •Age 18 to 75 years (inclusive) ; Body mass index (BMI) ≥ 18.5kg/m^2;
- •Histologically or cytologically confirmed advanced or recurrent endometrial cancer with measurable lesions
- •Patients who previously failed first-line systemic platinum-based therapy
- •ECOG PS (Eastern Cooperative Oncology Group performance status score) 0 or 1;
- •Need to provide tumor samples for central lab testing of biomarkers such as MSI(microsatellite instability) status;
- •Non-MSI-H(non-microsatellite instability-high) by central lab or previous test result indicating pMMR(proficient mismatch repair);
- •Adequate function of the major organs;
- •Expected survival ≥ 12 weeks;
- •Female patients of childbearing potential must have a negative serum pregnancy test within 7 days before randomization.
排除标准
- •Endometrial carcinosarcoma or sarcoma;
- •Known MMR(mismatch repair)/MSI status with dMMR(deficient mismatch repair) or MSI-H(microsatellite instability-high);
- •Toxicities related to prior anticancer therapy did not recover to ≤CTCAE Grade 1, except alopecia and oxaliplatin-induced peripheral neurotoxicity ≤CTCAE Grade 2;
- •Received systemic anti-tumor therapy approved within 4 weeks before randomization;
- •Other malignancies within the past 5 years;
- •Previous or screening central nervous system (CNS) metastases;
- •Radical radiotherapy within 4 weeks before randomization
- •Previously received any anti-programmed cell death receptor-1 (PD-1) antibody, anti-PD-L1(programmed death ligand-1) antibody, anti-PD-L2(programmed death ligand-2) antibody, or anti cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody or any other antibody acting on T cell costimulation or checkpoint pathways (eg, OX40, CD137, etc) or small molecule vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors;
- •Symptomatic or treatment-requiring thyroid dysfunction at screening;
- •Use of immunosuppressive agents within 4 weeks before randomization
- •Presence of any active autoimmune disease requiring systemic treatment or history of autoimmune disease within the past 2 years;
- •Systemic immunostimulants within 4 weeks before randomization;
- •Administration of any live or live-attenuated vaccine within 4 weeks before randomization or planned during the study;
- •Major surgical procedures within 4 weeks before randomization;
- •Uncontrolled malignant pleural effusion, ascites or pericardial effusion;
- •Patients with current hypertension uncontrolled by medication;
- •Patients with any current disease or condition affecting drug absorption, or patients unable to take oral medications;
- •Receiving strong inducers of cytochrome P450 3A4 enzyme;
- •Patients with gastrointestinal diseases or unresected tumors with active bleeding, or other conditions that may cause gastrointestinal bleeding and perforation as judged by the investigator; or with gastrointestinal perforation or gastrointestinal fistula, which is not recovered after surgical treatment;
- •Active bleeding within 3 weeks before randomization, or melena, or bleeding from a tumor within 2 weeks before the first dose ;
- •Tumor invading major vascular structures and is judged by the investigator to be at greater risk of massive haemorrhage;
- •Patients who had arterial thrombosis or deep venous thrombosis within 6 months before randomization; or patients who had stroke events and/or transient ischemic attack within 12 months; patients who had thrombosis caused by implantable intravenous infusion pump or catheter, except patients who had stable thrombosis after conventional anticoagulant therapy;
- •Clinically significant cardiovascular disease;
- •Clinically significant electrolyte abnormalities as judged by the investigator;
- •Active infection or fever of unknown origin before randomization;
- •Patients with active pulmonary tuberculosis (TB) receiving anti-tuberculosis treatment or anti-tuberculosis treatment within 1 year before randomization;
- •Patients with previous and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired pulmonary function, which may interfere with the detection and management of suspected drug-related pulmonary toxicity; previous or current (non-infectious) pulmonary inflammation requiring steroid hormone therapy;
- •Positive human immunodeficiency virus (HIV) antibody screening;
- •Known history of clinically significant liver disease
- •Known hypersensitivity to any of the study drugs or any of their excipients, or previous history of serious hypersensitivity to any other monoclonal antibody;
- •Patients who have received other clinical drugs that have not been approved or marketed within 4 weeks before randomization;
- •Women who are pregnant (positive pregnancy test before medication) or breastfeeding;
- •Patients who have received tissue/organ transplantation;
- •Patients with known psychiatric disorders or substance abuse disorders that could affect study compliance;
- •Patients who, in the opinion of the investigator, have other reasons that would make them inappropriate for this clinical study.
研究组 & 干预措施
Experimental group
Experimental
Patients will be treated with a planned dose of fruquintinib and sintilimab every three weeks until an IRC (independent review committee)-confirmed PD(disease progression) or meeting other discontinuation criteria.
干预措施: fruquintinib (Drug)
Experimental group
Experimental
Patients will be treated with a planned dose of fruquintinib and sintilimab every three weeks until an IRC (independent review committee)-confirmed PD(disease progression) or meeting other discontinuation criteria.
干预措施: sintilimab (Biological)
Control group
Active Comparator
Patients will be treated with TPC (chemotherapy of treating physician's choice, paclitaxel or doxorubicin) every three or four weeks until IRC-confirmed PD or meeting other discontinuation criteria.
干预措施: paclitaxel (Drug)
Control group
Active Comparator
Patients will be treated with TPC (chemotherapy of treating physician's choice, paclitaxel or doxorubicin) every three or four weeks until IRC-confirmed PD or meeting other discontinuation criteria.
干预措施: doxorubicin (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) as assessed by IRC
时间窗: Up to approximately 4 years
Progression-free survival (PFS) is defined as the time from randomization to disease progression assessed by IRC or death due to any cause, whichever occurs first.
Overall Survival (OS)
时间窗: Up to approximately 4 years
Overall Survival (OS) is defined as the time from randomization to death due to any cause.
次要结局
- Objective Response Rate (ORR)(Up to approximately 4 years)
- Duration of Response (DoR)(Up to approximately 4 years)
- Disease Control Rate (DCR)(Up to approximately 4 years)
- Time To Response (TTR)(Up to approximately 4 years)
- Progression-Free Survival (PFS) as assessed by investigator(Up to approximately 4 years)
- Incidence and severity of Treatment-emergent Adverse Events (TEAE)(Up to approximately 4 years)
- Blood concentration of fruquintinib(At the end of cycle 4 day 14 (each cycle is 21 days))
- Health-related quality of life (using EORTC QLQ-C30)(Up to approximately 4 years)
- Health-related quality of life (using EORTC QLQ-EN24)(Up to approximately 4 years)
研究者
研究点 (2)
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