NCT07191977尚未招募2 期
Neoadjuvant Camrelizumab With Palbociclib for the Treatment of Resectable Esophageal Squamous Cell Carcinoma: A Single-Arm Phase 2 Trial
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 41
- 主要终点
- Major Pathologic Response
研究概览
简要总结
The goal of this Phase 2 clinical trial is to learn if the combination of Camrelizumab and Palbociclib is a safe and effective treatment when given before surgery (neoadjuvant therapy) for patients with esophageal squamous cell carcinoma (ESCC) that can be surgically removed. Camrelizumab is an immunotherapy drug that helps the immune system fight cancer, and Palbociclib is a targeted therapy drug that stops cancer cells from growing.
The main questions it aims to answer are:
Is the combination of Camrelizumab and Palbociclib safe for patients to receive before their surgery? How effective is this treatment combination in shrinking tumors prior to surgery?
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
- •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)
Experimental
干预措施: Camrelizumab (Drug)
Camrelizumab+Palbociclib(100mg)
Experimental
干预措施: Palbociclib (Drug)
结局指标
主要结局
Major Pathologic Response
时间窗: up to 15 weeks
Major Pathologic Response (MPR) was defined as fewer than 10% viable tumor cells.
次要结局
- R0 resection rate(up to 15 weeks)
- Pathological Complete Response (PCR)(up to 15 weeks)
- Overall survival (OS)(Up to 2 years)
- Incidence of Treatment-Emergent Adverse Events(from the first dose to within 30 days after the last dose)
- Objective response rate (ORR)(up to 15 weeks)
研究者
Xingchen Peng
professor
West China Hospital
相似试验
进行中（未招募）
2 期
Camrelizumab Combined With AVD in the First-line Treatment for Patients With Advanced Classical Hodgkin's LymphomaClassical Hodgkin LymphomaNCT04067037Henan Cancer Hospital60
Unknown
不适用
Camrelizumab Combined With Albumin-bound Paclitaxel and S-1 in the Treatment of Advanced Gastric CancerAdvanced Gastric AdenocarcinomaNCT04675866Henan Cancer Hospital46
尚未招募
2 期
A Study of Concomitant Camrelizumab With Chemoradiation for Locally Advanced Head and Neck CancerHead and Neck NeoplasmsNCT04405154West China Hospital32
招募中
2 期
Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB NSCLCIMMUNOTHERAPYNeoadjuvant TherapyResectable Lung Non-Small Cell CarcinomaBiomarkers / BloodNCT06241807Shandong Cancer Hospital and Institute30
Unknown
不适用
Study of First-line Camrelizumab With or Without Chemotherapy for Advanced Esophageal Squamous Cell CancerEsophageal CancerNCT04654403The First Affiliated Hospital of Zhengzhou University337