Perioperative Toripalimab (JS001) Combined With Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
NCT ID: NCT04848753
Last Updated: 2023-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
663 participants
INTERVENTIONAL
2021-06-23
2027-05-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Experimental Group
Toripalimab combined with cisplatin and paclitaxel
Toripalimab combined with cisplatin and paclitaxel
Specified doses on specified days.
Control Group
Placebo combined with cisplatin and paclitaxel
Placebo combined with cisplatin and paclitaxel
Specified doses on specified days.
Interventions
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Toripalimab combined with cisplatin and paclitaxel
Specified doses on specified days.
Placebo combined with cisplatin and paclitaxel
Specified doses on specified days.
Eligibility Criteria
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Inclusion Criteria
2. No suspicious cervical lymph node metastasis on cervical contrast-enhanced CT; no systemic metastasis from radiological examination;
3. Expected to be achievable to conduct R0 resection.
Exclusion Criteria
2. Combined with other inoperable condition;
3. Previous serious allergy to chemotherapeutic agents (paclitaxel or cisplatin) or any monoclonal antibody;
4. Combined with other conditions unsuitable for participation in this study as judged by investigators.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Junshi Bioscience Co., Ltd.
OTHER
Responsible Party
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Principal Investigators
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Lin Shen
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Yongtao Han
Role: PRINCIPAL_INVESTIGATOR
Sichuan Cancer Hospital and Research Institute
Yan Zheng
Role: PRINCIPAL_INVESTIGATOR
Henan Cancer Hospital
Keneng Chen
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
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The Firest Affiliated Hospital of bengbu Medical College
Bengbu, Anhui, China
Anhui provincial hospital
Hefei, Anhui, China
The Second Hospital of anhui Medical University
Hefei, Anhui, China
Jiangmen central Hospital
Jiangmen, Guangdong, China
Shenzhen people's hosptial
Shenzhen, Guangdong, China
The fourth hospital of hebei medical university
Shijiazhuang, Hebei, China
Anyang Cancer Hospital
Anyang, Henan, China
The First Affiliated Hospital of xinxiang Medical University
Xinxiang, Henan, China
Henan provincial pepples hospital
Zhengzhou, Henan, China
The first affilated hospital of zhengzhou university
Zhengzhou, Henan, China
Hunan provincial cancer hospital
Changsha, Hunan, China
China-Japan Union hosptial of Jilin university
Changchun, Jilin, China
The first affiliated hospital of jinzhou medical university
Jinzhou, Niaoning, China
Shanxi provincial cancer hosptial
Taiyuan, Shanxi, China
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Hwa Mei Hospital,University of Chinese Academy of sciences
Ningbo, Zhejiang, China
Taizhou hospital of zhejiang province
Taizhou, Zhejiang, China
Beijing Cancer Hospital
Beijing, , China
Peking University Third Hospital
Beijing, , China
The General Hospital of People's Liberation Army
Beijing, , China
Heping Hospital Affiliated to changzhi Medical College
Changzhi, , China
Sichuan Cancer Hospital & Institute
Chengdu, , China
Fujian Cancer Hospital
Fuzhou, , China
3201 Hospital
Hangzhou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hanzhou, , China
harbin medical university Cancer Hospital
Harbin, , China
Anhui Provincial Cancer Hospital
Hefei, , China
Huai'an First People's Hospital
Huai'an, , China
The Affiliated Hospital of jining Medical University
Jining, , China
The First Affiliated Hospital of nanchang University
Nanchang, , China
Jiangsu Cancer Hospital
Nanjing, , China
The Affiliated Hospital of Qingdao University
Qingdao, , China
Zhongshan Hospital Fudan University
Shanghai, , China
Shantou University Cancer Hospital
Shantou, , China
Liaoning cancer hospital& Institute
Shenyang, , China
Shengjing Hospital of China Medical University
Shenyang, , China
The first Hospital of china Medical University
Shenyang, , China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, , China
Hubei Cancer Hospital
Wuhan, , China
Renmin Hospital of Wuhan University
Wuhan, , China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, , China
The First Affiliated Hospital of Xiamen University
Xiamen, , China
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, , China
Xinyang central Hospital
Xinyang, , China
The Affiliated Hospital of xuzhou Medical University
Xuzhou, , China
Yantai yuhuangding Hospital
Yantai, , China
Henan Cancer Hospital
Zhengzhou, , China
Countries
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Other Identifiers
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JS001-042-III-ESCC
Identifier Type: -
Identifier Source: org_study_id
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