NCT04848753进行中（未招募）3 期
A Phase III Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Perioperative Toripalimab (JS001) Combined With Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
Shanghai Junshi Bioscience Co., Ltd.49 个研究点 分布在 1 个国家目标入组 663 人开始时间: 2021年6月23日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 663
- 试验地点
- 49
- 主要终点
- To compare IRC-assessed events-free survival (EFS) in 2 arms
研究概览
简要总结
This is a randomized, placebo-controlled, multi-center, double-blinded, Phase III study to determine the efficacy and safety of patients with locally advanced squamous cell carcinoma of the thoracic esophagus treated with perioperative immunotherapy combined with neoadjuvant chemotherapy versus placebo combined with neoadjuvant chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 must fulfill all of the following inclusion criteria to be eligible for enrollment in this study:
- •Histologically confirmed locally advanced (T1N1-3M0 or T2-3N0-3M0) squamous cell carcinoma of the thoracic esophagus (per the 8th Edition of UICC-TNM Classification);
- •No suspicious cervical lymph node metastasis on cervical contrast-enhanced CT; no systemic metastasis from radiological examination;
- •Expected to be achievable to conduct R0 resection.
- •Patients must not enter this study if any of the following
排除标准
- •is fulfilled:
- •Having malignant tumors other than esophageal carcinoma within 5 years prior to randomization;
- •Combined with other inoperable condition;
- •Previous serious allergy to chemotherapeutic agents (paclitaxel or cisplatin) or any monoclonal antibody;
- •Combined with other conditions unsuitable for participation in this study as judged by investigators.
- •Other protocol defined Inclusion/exclusion criteria could apply.
结局指标
主要结局
To compare IRC-assessed events-free survival (EFS) in 2 arms
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 60 months
次要结局
- 1-year OS rate(from randomization to death from any cause at 1 year)
- 3- year OS rate(from randomization to death from any cause at 3 year)
- 5- year OS rate(from randomization to death from any cause at 5 year)
- pathologically complete remission (pCR) rate(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 60 months)
- Investigator-assessed EFS according to RECIST v1.1(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 60 months)
- Overall survival(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed approximately up to 60 months)
研究者
研究点 (49)
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