The Safety and Feasibility of Neoadjuvant Adebrelimab With Dalpiciclib for the Treatment of Resectable Esophageal Squamous Cell Carcinoma：A Phase 1 Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Safety of combination adebrelimab and dalpiciclib as assessed by number of participants who experience adverse events
研究概览
简要总结
The purpose of this study is to explore the safety and feasibility of anti-programmed cell death ligand 1(PD-L1) immunotherapy, Adebrelimab, combined with cyclin-dependent kinase 4/6 blockade, Dalpiciclib, as a new neoadjuvant treatment regimen for patients with resectable esophageal squamous cell carcinoma (ESCC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Patients diagnosed with esophageal squamous cell cancer by gastroscopic biopsies.
- •The primary tumor should be located in the thorax.
- •The patients should be evaluated to be able to have surgical resection before the surgery according to the examinations .
- •The patients should be at the range of 18-75 years old, Eastern Cooperative Oncology Group (ECOG) 0-
- •The patients should be able to understand our research and be willing to accept surgical treatment and sign the informed consent.
排除标准
- •The stage of tumor is T4b (AJCC/International Union Against Cancer (UICC) 8th Edition) and cannot be resected.
- •Currently undergoing other chemotherapy, radiotherapy, targeted therapy or immunotherapy.
- •History of other malignancies.
- •Have an active autoimmune disease requiring systemic treatment or a documented history of clinically severe autoimmune disease.
- •Any history of allergic disease, or a sever hypersensitivity reaction to drugs, or allergy to the study drug components.
- •Presence of serious medical diseases, such as grade II and above cardiac dysfunction (NYHA criteria), ischemic heart diseases, etc.
- •The patients with severe systematic intercurrent diseases, including active infection or poorly controlled diabetes, coagulation disorders, hemorrhagic tendency, or those undergoing thrombolysis or anticoagulant therapy, are excluded from the study.
- •Female participants who test positive for a serum pregnancy test, are in the lactation period, or are at a childbearing stage and unwilling to use contraception measures during the research are excluded.
- •Received any investigational drug within 4 weeks prior to the first dose, or concurrently enrolled in another clinical trial.
- •Any other factors that are not suitable for inclusion in this study judged by investigators.
研究组 & 干预措施
Adebrelimab+Dalpiciclib(100mg)
Adebrelimab will be given at a dose of 20 mg per kilogram of body weight every three weeks on day 23 of a planned 28-day cycle, and two doses before surgery.
Dalpiciclib will be given at a dose of 100 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles.
For dalpiciclib, there is 2 dose levels, 100mg qd and 150 mg qd, and if no patients experience DLT on 100mg level, 150mg level will be administered.
干预措施: Adebrelimab (Drug)
Adebrelimab+Dalpiciclib(100mg)
Adebrelimab will be given at a dose of 20 mg per kilogram of body weight every three weeks on day 23 of a planned 28-day cycle, and two doses before surgery.
Dalpiciclib will be given at a dose of 100 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles.
For dalpiciclib, there is 2 dose levels, 100mg qd and 150 mg qd, and if no patients experience DLT on 100mg level, 150mg level will be administered.
干预措施: Dalpiciclib 100mg (Drug)
Adebrelimab+Dalpiciclib(150mg)
Adebrelimab will be given at a dose of 20 mg per kilogram of body weight every three weeks on day 23 of a planned 28-day cycle, and two doses before surgery.
Dalpiciclib will be given at a dose of 100 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles.
For dalpiciclib, there is 2 dose levels, 100mg qd and 150 mg qd, and if no patients experience DLT on 100mg level, 150mg level will be administered.
干预措施: Adebrelimab (Drug)
Adebrelimab+Dalpiciclib(150mg)
Adebrelimab will be given at a dose of 20 mg per kilogram of body weight every three weeks on day 23 of a planned 28-day cycle, and two doses before surgery.
Dalpiciclib will be given at a dose of 100 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles.
For dalpiciclib, there is 2 dose levels, 100mg qd and 150 mg qd, and if no patients experience DLT on 100mg level, 150mg level will be administered.
干预措施: Dalpiciclib 150mg (Drug)
结局指标
主要结局
Safety of combination adebrelimab and dalpiciclib as assessed by number of participants who experience adverse events
时间窗: up to 15 weeks
Number of participants who experience grade 1 or higher adverse events, as defined by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Feasibility of combination adebrelimab and dalpiciclib as assessed by number of participants who experience adverse events
时间窗: up to 15 weeks
Patients proceed to surgery without experiencing prolonged treatment-related delays. An extended treatment-related delay will be considered if it exceeds 37 days from the initially scheduled surgery date. In terms of feasibility, if there is any treatment toxicity of any grade that could adversely impact prognosis, as judged by the investigators, the planned operative date should be re-evaluated.
次要结局
- Maximum Tolerated Dose (MTD) of dalpiciclib as determined by number of participants with dose limiting toxicities (DLT)(up to 15 weeks)
- Objective response rate (ORR)(up to 15 weeks)
- Major Pathologic Response(up to 15 weeks)
- Progression free survival(PFS)(Up to 2 years)
- Overall survival (OS)(Up to 2 years)
研究者
Xingchen Peng
professor
West China Hospital