The Safety and Feasibility of Neoadjuvant Camrelizumab With Palbociclib 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 camrelizumab and palbociclib 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 1(PD-1) immunotherapy, Camrelizumab, combined with cyclin-dependent kinase 4/6 blockade, Palbociclib, 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
- 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
- •Patients diagnosed with esophageal squamous cell cancer by gastroscopic biopsies.
- •The primary tumor should be located in the thorax and evaluated resectable( cT1b-T3N1-3M0, cT3N0M0) by CT/MRI/EUS
- •The patients should be at the range of 18-75 years old, Eastern Cooperative Oncology Group (ECOG) 0-
- •The patients should have no functional disorders in major organs. Blood routine tests, as well as lung, liver, kidney, and heart functions should be basically normal.
- •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 etc. 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
Camrelizumab+Palbociclib(100mg) 3 patients
For palbociclib, there is 2 dose levels, 100mg qd and 125 mg qd, and if no patients experience DLT on 100mg level, 125mg level will be administered.
干预措施: Camrelizumab (Drug)
Camrelizumab+Palbociclib(100mg) 3 patients
For palbociclib, there is 2 dose levels, 100mg qd and 125 mg qd, and if no patients experience DLT on 100mg level, 125mg level will be administered.
干预措施: Palbociclib(100mg) (Drug)
Camrelizumab+Palbociclib(125mg) 3 patients
For palbociclib, there is 2 dose levels, 100mg qd and 125 mg qd, and if no patients experience DLT on 100mg level, 125mg level will be administered.
干预措施: Camrelizumab (Drug)
Camrelizumab+Palbociclib(125mg) 3 patients
For palbociclib, there is 2 dose levels, 100mg qd and 125 mg qd, and if no patients experience DLT on 100mg level, 125mg level will be administered.
干预措施: Palbociclib(125mg) (Drug)
结局指标
主要结局
Safety of combination camrelizumab and palbociclib 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 camrelizumab and palbociclib 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 palbociclib as determined by number of participants with dose limiting toxicities (DLT)(up to 15 weeks)
- Major Pathologic Response(up to 15 weeks)
- Objective response rate (ORR)(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
Sichuan University