NCT05163483招募中2 期
Tucidinostat in Combination With PD-1 Inhibitor and Bevacizumab as Late-line Treatment in Patients With Advanced Esophageal Squamous Cell Cancer, Adenocarcinoma of Esophagogastric Junction and Gastric Adenocarcinoma
Ruihua Xu1 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2022年7月1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
- 87
- 试验地点
- 1
- 主要终点
- Objective Response Rate（ORR）
研究概览
简要总结
This Phase II study was designed to assess the efficacy and safety of the combination of PD-1 inhibitor, Tucidinostat (chidamide), a histone deacetylase inhibitor, and bevacizumab in advanced Esophageal squamous cell cancer, adenocarcinoma of esophagogastric junction, Gastric adenocarcinoma patients.
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
- •Age ≥18 years, ≤ 75 years
- •Histologically or cytologically confirmed Esophageal squamous cell cancer, adenocarcinoma of esophagogastric junction and Gastric adenocarcinoma, unresectable, recurrent or metastatic disease.
- •Can provide at least 5 pieces of pathological section or fresh tumor tissue
- •Eastern Collaborative Oncology Group (ECOG) ≤
- •≤2 systemic chemotherapy for advanced disease (total number of treatment lines for advanced disease ≤4).
- •Patients who have previously used PD-1 antibodies, PD-L1 antibodies, PD-L2 antibodies, or CTLA-4 antibodies (or any other antibodies acting on T cell co-stimulation or checkpoint pathways) or require a duration of ≥16 weeks;
- •Adequate organ function.
- •Life expectancy is more than 3 months.
- •For females of child bearing potential, a negative urine or serum pregnancy test result within 3 days before study treatment.
- •Willing and able to provide written informed consent.
排除标准
- •Allergies to any monoclonal antibody or Tucidinostat preparation have been known, and hypersensitivity reactions of more than 3 levels have occurred
- •Previously received immunotherapy and had grade 3 or above immune-related adverse events.
- •Previously received histone deacetylase inhibitors,or toripalimab, or angiogenesis inhibitors.
- •Subjects with any active, known or suspected autoimmune disease or history of autoimmune disease.
- •Known active CNS metastases and/or carcinomatous meningitis.
- •Received a live vaccine within 4 weeks of the first dose of study medication.
- •Major surgery received or severe traumatic injury, fracture, or ulcer occurred within 4 weeks of the first dose of study medication.
- •Pregnant or lactating female.
- •Uncontrolled clinically significant systemic diseases, including active infection, unstable angina, angina occurred within 3 months,≥ NYHA II congestive heart failure, myocardial infarction occurred within 6 months, severe arrhythmia, liver, kidney, or metabolic disease.
- •Participate in other clinical trials currently or within 4 weeks prior to enrollment.
研究组 & 干预措施
Tucidinostat (chidamide), PD-1 inhibitor （Toripalimab), Bevacizumab
Experimental
Tucidinostat (chidamide), 30mg, po., biw, q3w Toripalimab, 240mg, ivgtt., d1, q3w Bevacizumab, 7.5mg/kg, ivgtt., d1, q3w
approximately 2 years
干预措施: Tucidinostat (chidamide), PD-1 inhibitor (Toripalimab), Bevacizumab (Drug)
结局指标
主要结局
Objective Response Rate（ORR）
时间窗: 2 years
Objective Response Rate（ORR）by RECIST 1.1,the total proportion of patients with complete response（CR）, partial response（PR）
次要结局
- Progression-free survival(PFS)(2 years)
- Disease Control Rate （DCR）(2 years)
- Duration of Response（DoR）(2 years)
- Overall survival(OS)(3 years)
研究者
Ruihua Xu
Sun Yat-sen University cancer center
Sun Yat-sen University
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
Chidamide and PD-1 Inhibitor Plus Anlotinib for HER2-low Breast Cancer That Has Spread or Cannot be Surgically RemovedBreast CancerNCT06547476Guangdong Provincial People's Hospital40
尚未招募
2 期
Efficacy and Safety of Sintilimab Combined with Nab-PP Plus Rh-endostatin in Locally Advanced/advanced and Recurrent Metastatic Squamous Non-small Cell Lung Cancer: a Single-arm, Multicenter Clinical StudySquamous Non-Small Cell Lung Cancer SqNSCLCNCT06747169Jian-Guo Zhou, MD, PhD32
尚未招募
2 期
Tucidinostat Plus Apatinib for Advanced OsteosarcomaOsteosarcomaNCT06125171Wuhan Union Hospital, China46
招募中
2 期
PD-1 Inhibitor or PD-1 Inhibitor Plus GVD for Relapsed/Refractory CHLClassical Hodgkin LymphomaRefractory or Relapsed Classical Hodgkin LymphomaNCT04624984Sun Yat-sen University42
尚未招募
2 期
Phase II Study of the Combination of Irinotecan and POF (POFI) and Tislelizumab in Advanced Gastric CancerGastric CancerNCT06197438Fujian Cancer Hospital36