NCT06497985招募中3 期
A Randomised, Open-label, Multicenter Phase III Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients Who Failed at Least Second-line Standard Therapies
Chipscreen Biosciences, Ltd.1 个研究点 分布在 1 个国家目标入组 430 人开始时间: 2024年11月27日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 430
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
A randomised, open-label, multicenter phase III study to evaluate the efficacy and safety of tucidinostat in combination with sintilimab and bevacizumab versus fruquintinib monotherapy in MSS/pMMR colorectal cancer patients.
详细描述
This is a randomised, open-label, multicenter phase III study evaluating the efficacy and safety of tucidinostat in combination with sintilimab and bevacizumab versus fruquintinib monotherapy in MSS/pMMR colorectal cancer patients. 430 patients will be randomised (1:1) to receive tucidinostat in combination with sintilimab and bevacizumab (experimental arm) or fruquintinib monotherapy (control arm).
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
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent for the study.
- •Age ≥18 years and ≤75 years.
- •Histologically or cytologically confirmed unresectable and metastatic colorectal adenocarcinoma.
- •Has been previously treated and has shown disease progression or could not tolerate standard treatment, which must include fluoropyrimidine, irinotecan and oxaliplatin, with or without an anti-vascular endothelial growth factor (VEGF) monoclonal antibody (bevacizumab) or anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (cetuximab or panitumumab) .
- •Have confirmed MSS or MSI-L, or pMMR.
- •KRAS status must have been previously determined (mutant or wild-type) .
- •Measurable disease per RECIST v1.
- •ECOG PS 0 or
- •Adequate organ function.
- •Expected survival >12 weeks.
排除标准
- •Prior use of HDAC inhibitor.
- •Received prior therapies targeting PD-1, PD-L1, CTLA4, or any other immune checkpoint pathway.
- •Prior use of small-molecule tyrosine kinase inhibitor of VEGF receptors.
- •Received any anti-tumor therapy or investigational agent and device within 28 days before the first dose of study treatment.
- •Received radiotherapy within 28 days before the first dose of study treatment.
- •If randomized into the control group, it is planned to use the combination of tucidinostat with PD-1 inhibitor and bevacizumab after the end of study treatment.
- •History of autoimmune diseases requiring systemic treatment within 2 years before the first dose of study treatment.
- •Known history of primary immunodeficiency.
- •Received systemic immunosuppressive drugs within 28 days before the first dose of study treatment.
- •Received systemic immunostimulatory drugs within 28 days before the first dose of study treatment.
- •Received major surgery within 28 days before the first dose of study treatment.
- •Received a live vaccine within 28 days before the first dose of study treatment or planned to receive during the study period.
- •Has not recovered ( ≤ Grade 1 defined by CTCAE V5.0) from AEs due to prior anti-cancer therapy.
- •Has uncontrolled diabetes assessed by investigators within 7 days before the first dose of study treatment.
- •Has symptomatic and untreated central nervous system (CNS) metastases.
- •Has uncontrollable or major cardiovascular disease.
- •History of cerebrovascular accidents within 6 months before the first dose of study treatment.
- •History of serious thromboembolism within 6 months before the first dose of study treatment.
- •History of gastrointestinal perforation and/or fistula etc., within 6 months before the first dose of study treatment.
- •Obvious gastrointestinal abnormalities during the screening period,which may affect the intake, transport or absorption of drugs.
- •Known history of bleeding disorders or coagulopathy.
- •Anticoagulants or thrombolytic agents are being used during the screening period.
- •Uncontrolled pleural/abdominal/pericardial effusion that was drained within 14 days before the first dose of study treatment.
- •Suspected interstitial lung disease (ILD) or pulmonary fibrosis or pulmonary inflammation requiring treatment.
- •Severe or active infection requiring systemic therapy.
- •Known active pulmonary tuberculosis.
- •Active hepatitis B or hepatitis C.
- •HIV positive or syphilis infection.
- •History of malignant tumor.
- •History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- •History of hypersensitivity to study drugs, or any of its excipients.
- •History of alcohol or drug abuse.
- •Unwilling or unable to comply with procedures required in this protocol.
- •Pregnant or breast-feeding women. Male/Female is unwilling or unable to use a highly effective method of birth control.
- •Any condition not suitable for participating in the trial in the opinion of the Investigator.
研究组 & 干预措施
tucidinostat+sintilimab+bevacizumab
Experimental
干预措施: Tucidinostat (Drug)
tucidinostat+sintilimab+bevacizumab
Experimental
干预措施: Sintilimab (Drug)
tucidinostat+sintilimab+bevacizumab
Experimental
干预措施: Bevacizumab (Drug)
fruquintinib
Active Comparator
干预措施: Fruquintinib (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to approximately 2 years
From randomization to the date of death from any cause.
次要结局
- Disease control rate (DCR)(Up to approximately 2 years)
- Change From Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Health Utility Index Scores(Up to approximately 2 years)
- Progression Free Survival (PFS)(Up to approximately 2 years)
- Overall response rate (ORR)(Up to approximately 2 years)
- Change From Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score(Up to approximately 2 years)
- Duration of response (DOR)(Up to approximately 2 years)
- Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life Scale Score(Up to approximately 2 years)
- Safety and Tolerability(Up to approximately 2 years)
- Plasma concentrations of tucidinostat(Up to approximately 6 months)
研究者
研究点 (1)
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