NCT03829969已完成3 期
A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Compare Toripalimab Injection (JS001) Combined With Standard Chemotherapy Versus Placebo Combined With Standard Chemotherapy in Treatment of Advanced or Metastatic Esophageal Squamous Cell Cancer (ESCC) Without Previous Systemic Chemotherapy
Shanghai Junshi Bioscience Co., Ltd.1 个研究点 分布在 1 个国家目标入组 514 人开始时间: 2019年1月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 514
- 试验地点
- 1
- 主要终点
- OS (Overall Survival)
研究概览
简要总结
This is one randomized, double-blind, multi-center, placebo-controlled phase III study. The objective of this study is to compare the effectiveness and safety of JS001 combined with paclitaxel and cisplatin(TP regimen )with placebo combined with TP regimen in patients with advanced or metastatic Esophageal Squamous Cell Carcinoma(ESCC )who have not received systemic chemotherapy previously.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Toripalimab
Experimental
Toripalimab combine with paclitaxel and cisplatin
干预措施: Toripalimab (Biological)
placebo
Placebo Comparator
Placebo combine with paclitaxel and cisplatin
干预措施: Toripalimab (Biological)
结局指标
主要结局
OS (Overall Survival)
时间窗: up to 2 years
To evaluate the differences in OS following JS001 in combination with TP regimen compared to placebo in combination with TP regimen in all randomized patient population with advanced or metastatic ESCC who had not previously received systemic chemotherapy (as assessed by blinded independent central review \[BICR\] per RECIST 1.1 criteria)
PFS((Progression-Free Surviv)
时间窗: PFS: up to 2years
To evaluate the differences in PFS following JS001 in combination with TP regimen compared to placebo in combination with TP regimen in all randomized patient population with advanced or metastatic ESCC who had not previously received systemic chemotherapy (as assessed by blinded independent central review \[BICR\] per RECIST 1.1 criteria).
次要结局
- DOR(Duration of Response: Recist 1.1,BICR )(Up to 2 approximately years)
- TTR(Time to Initial Response:BICR )(Up to 2 approximately years)
- PFS(Up to 2 approximately years)
- ORR(Overall Response Rate:BICR)(Up to 2 approximately years)
- DCR(Disease Control Rate:BICR )(Up to 2 approximately years)
- OS Rate(up to 2 years)
- DoR Assessed Per irRECIST:BICR(From date of response until progressive disease. Up to 2 approximately years)
- TTR Assessed Per irRECIST:BICR(From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years)
- Patient-Reported Outcomes Collected Via the EORTC QLQ-C30(From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years)
- PFS Rate:BICR(Up to 1 years)
- PFS Assessed Per irRECIST(From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years)
- ORR Assessed Per irRECIST(From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years)
- DCR Assessed Per irRECIST(From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years)
- Patient-Reported Outcomes Collected Via the EORTC QLQ-OES18(From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years)
研究者
研究点 (1)
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相关资讯
Long-Term Follow-Up Data Confirm Sustained Survival Benefits of PD-1 Inhibitors in Nasopharyngeal and Esophageal Cancers- Extended follow-up from the RATIONALE-309 trial shows tislelizumab plus chemotherapy maintained progression-free survival benefits in recurrent or metastatic nasopharyngeal cancer patients after 3 years.
- Six-year follow-up data from JUPITER-02 demonstrates toripalimab plus chemotherapy achieved median overall survival of 64.8 months versus 33.7 months with chemotherapy alone in nasopharyngeal carcinoma.
- Final analysis of JUPITER-06 confirms toripalimab plus chemotherapy significantly improved overall survival to 17.7 months versus 12.9 months with placebo in advanced esophageal squamous cell carcinoma.
- Biomarker analyses identified activated immune signatures and specific genomic alterations as potential predictors of enhanced treatment response to PD-1 inhibitor combinations.6 months agoUK MHRA Approves Junshi Biosciences' Toripalimab for Nasopharyngeal and Esophageal Cancers- The UK MHRA has approved toripalimab for recurrent or metastatic nasopharyngeal carcinoma (NPC) in combination with cisplatin and gemcitabine.
- Toripalimab is also approved in combination with cisplatin and paclitaxel for unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).
- Toripalimab is the first and only drug approved in the UK for NPC treatment and the only first-line treatment for advanced or metastatic ESCC, regardless of PD-L1 status.
- Approvals are based on Phase 3 trials JUPITER-02 and JUPITER-06, demonstrating significant improvements in progression-free and overall survival.last yearUK MHRA Approves Junshi Biosciences' Toripalimab for Nasopharyngeal and Esophageal Cancers- The UK MHRA has approved toripalimab for treating recurrent or metastatic nasopharyngeal carcinoma (NPC) in combination with cisplatin and gemcitabine.
- Toripalimab is also approved in combination with cisplatin and paclitaxel for unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).
- This marks toripalimab as the first and only drug approved in the UK for NPC treatment and the only first-line option for advanced or metastatic ESCC, irrespective of PD-L1 status.
- Approvals are based on Phase 3 trials JUPITER-02 for NPC and JUPITER-06 for ESCC, demonstrating significant improvements in progression-free and overall survival.last yearToripalimab Approved in India, Hong Kong, and Europe for Nasopharyngeal and Esophageal Cancers- Toripalimab gains approval in India and Hong Kong for recurrent or metastatic nasopharyngeal carcinoma (NPC) as both a first-line combination therapy and a single-agent treatment.
- The European Commission approves toripalimab in combination with chemotherapy for first-line treatment of recurrent or metastatic NPC and esophageal squamous cell carcinoma (ESCC).
- Approvals are based on Phase 3 JUPITER-02 and JUPITER-06 trials, demonstrating significant improvements in progression-free and overall survival compared to chemotherapy alone.
- Toripalimab, developed by Junshi Biosciences, is now approved in over 30 countries and regions, marking a significant expansion of its global commercial strategy.last year