NCT06903871尚未招募2 期
A Prospective, Randomized, Open-label, Controlled Clinical Study Comparing Toripalimab Adjuvant Therapy Versus Clinical Observation in Subjects With Resected Esophageal Squamous Cell Carcinoma Who Achieved Pathological Complete Response (pCR)
Hebei Medical University Fourth Hospital1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2025年4月1日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- 1-year Disease free survival rate
研究概览
简要总结
The goal of this clinical trial is to assess the 1-year DFS rate of toripalimab adjuvant therapy in participants with resected esophageal squamous cell carcinoma (ESCC) who achieved pCR. The main questions it aims to answer are:
- The toripalimab adjuvant therapy could impove the 1-year DFS rate in participants with rescted ESCC who achieved pCR?
- Is this treatment regimen safe? Researchers will compare toripalimab adjuvant therapy to clinical observation to see if toripalimab could improve the 1-year DFS rate.
Participants will receive toripalimab 240 mg IV once every 3 weeks for one year or clinical observation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage II or III esophageal cancer with histologically confirmed predominant squamous cell carcinoma at initial diagnosis;
- •Subjects must complete preoperative neoadjuvant therapy (unlimited treatment regimen) before being assigned to treatment and then undergo surgery;
- •Subjects must undergo complete resection (R0), be surgically determined to be disease-free and have a negative margin on the resected specimen, defined as no viable tumor within 1 mm of the proximal, distal, or surrounding resection boundary;
- •Subjects must have no residual pathology, the primary tumor is pCR, and the pathology report of the resected lymph nodes is ypN0;
- •ECOG performance status of 0 or 1;
- •The laboratory test meet the following requirements:
- •Bone marrow function: neutrophils ≥ 1.5×10(9)/L, platelets ≥ 100×10(9)/L, hemoglobin ≥ 90 g/L Liver function：Total bilirubin ≤ 1.5 x ULN；AST and ALT ≤ 3 x ULN Renal function：Cr ≤ 1.5 x ULN，Ccr ≥ 50 ml/min.
排除标准
- •Subjects with stage M1 resectable disease；
- •Received treatments for resected esophageal cancer (e.g., immunotherapy , chemotherapy, targeted therapy, radiotherapy, or biologic therapy);
- •Known to be allergic, highly sensitive or intolerable to research-related drugs or excipient
- •In the past 5 years, there were other malignant tumors, melanoma skin cancer or ervical carcinoma in situ were excepted.
研究组 & 干预措施
Toripalimab
Experimental
干预措施: TORIPALIMAB INJECTION(JS001 ) (Drug)
结局指标
主要结局
1-year Disease free survival rate
时间窗: 1 year
次要结局
- 1, 2, 3 years overall survival rates(3 years)
- Distant metastasis-free survival(2 years)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(1.5 years)
研究者
JunFeng Liu, MD
Director of thoracic surgery
Hebei Medical University Fourth Hospital
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Safety, Tolerability and Pharmacokinetics of an Anti-PD-1 Monoclonal Antibody in Subjects With Advanced MalignanciesAdvanced MalignanciesNCT03474640TopAlliance Biosciences184
招募中
2 期
Neoadjuvant Toripalimab for Clinically Stage II-IIIB Resectable Non-small Cell Lung Cancer with EGFR Mutation and PD-L1 Positive ExpressionCarcinoma, Non-Small-Cell LungNCT06269211Ruijin Hospital29
尚未招募
2 期
Neoadjuvant Toripalimab Combined With Chemotherapy in the Treatment of Malignant Pleural MesotheliomaMalignant Pleural MesotheliomaNCT04713761Shanghai Pulmonary Hospital, Shanghai, China15
招募中
2 期
Neoadjuvant PD-1 Inhibitor Combined With Cetuximab and Platinum in Resectable Locally Advanced Hypopharyngeal CarcinomaLocally Advanced Hypopharyngeal CarcinomaNCT06151743Eye & ENT Hospital of Fudan University32
招募中
2 期
Phase II Study of Serplulimab Combined with First-Line Targeted Therapy, Chemotherapy, and Radiation in Advanced Colorectal CancerAdvanced Colorectal CarcinomaImmunotherapyNCT06521866Fudan University208