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

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

663 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-23

Study Completion Date

2027-05-12

Brief Summary

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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.

Detailed Description

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Conditions

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Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental Group

Toripalimab combined with cisplatin and paclitaxel

Group Type ACTIVE_COMPARATOR

Toripalimab combined with cisplatin and paclitaxel

Intervention Type COMBINATION_PRODUCT

Specified doses on specified days.

Control Group

Placebo combined with cisplatin and paclitaxel

Group Type PLACEBO_COMPARATOR

Placebo combined with cisplatin and paclitaxel

Intervention Type COMBINATION_PRODUCT

Specified doses on specified days.

Interventions

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Toripalimab combined with cisplatin and paclitaxel

Specified doses on specified days.

Intervention Type COMBINATION_PRODUCT

Placebo combined with cisplatin and paclitaxel

Specified doses on specified days.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

1. 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);
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

1. Having malignant tumors other than esophageal carcinoma within 5 years prior to randomization;
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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Junshi Bioscience Co., Ltd.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Anhui provincial hospital

Hefei, Anhui, China

Site Status

The Second Hospital of anhui Medical University

Hefei, Anhui, China

Site Status

Jiangmen central Hospital

Jiangmen, Guangdong, China

Site Status

Shenzhen people's hosptial

Shenzhen, Guangdong, China

Site Status

The fourth hospital of hebei medical university

Shijiazhuang, Hebei, China

Site Status

Anyang Cancer Hospital

Anyang, Henan, China

Site Status

The First Affiliated Hospital of xinxiang Medical University

Xinxiang, Henan, China

Site Status

Henan provincial pepples hospital

Zhengzhou, Henan, China

Site Status

The first affilated hospital of zhengzhou university

Zhengzhou, Henan, China

Site Status

Hunan provincial cancer hospital

Changsha, Hunan, China

Site Status

China-Japan Union hosptial of Jilin university

Changchun, Jilin, China

Site Status

The first affiliated hospital of jinzhou medical university

Jinzhou, Niaoning, China

Site Status

Shanxi provincial cancer hosptial

Taiyuan, Shanxi, China

Site Status

Affiliated Tumor Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Site Status

Hwa Mei Hospital,University of Chinese Academy of sciences

Ningbo, Zhejiang, China

Site Status

Taizhou hospital of zhejiang province

Taizhou, Zhejiang, China

Site Status

Beijing Cancer Hospital

Beijing, , China

Site Status

Peking University Third Hospital

Beijing, , China

Site Status

The General Hospital of People's Liberation Army

Beijing, , China

Site Status

Heping Hospital Affiliated to changzhi Medical College

Changzhi, , China

Site Status

Sichuan Cancer Hospital & Institute

Chengdu, , China

Site Status

Fujian Cancer Hospital

Fuzhou, , China

Site Status

3201 Hospital

Hangzhou, , China

Site Status

Zhejiang Cancer Hospital

Hangzhou, , China

Site Status

The First Affiliated Hospital, Zhejiang University School of Medicine

Hanzhou, , China

Site Status

harbin medical university Cancer Hospital

Harbin, , China

Site Status

Anhui Provincial Cancer Hospital

Hefei, , China

Site Status

Huai'an First People's Hospital

Huai'an, , China

Site Status

The Affiliated Hospital of jining Medical University

Jining, , China

Site Status

The First Affiliated Hospital of nanchang University

Nanchang, , China

Site Status

Jiangsu Cancer Hospital

Nanjing, , China

Site Status

The Affiliated Hospital of Qingdao University

Qingdao, , China

Site Status

Zhongshan Hospital Fudan University

Shanghai, , China

Site Status

Shantou University Cancer Hospital

Shantou, , China

Site Status

Liaoning cancer hospital& Institute

Shenyang, , China

Site Status

Shengjing Hospital of China Medical University

Shenyang, , China

Site Status

The first Hospital of china Medical University

Shenyang, , China

Site Status

Tianjin Medical University Cancer Institute and Hospital

Tianjin, , China

Site Status

Hubei Cancer Hospital

Wuhan, , China

Site Status

Renmin Hospital of Wuhan University

Wuhan, , China

Site Status

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, , China

Site Status

The First Affiliated Hospital of Xiamen University

Xiamen, , China

Site Status

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, , China

Site Status

Xinyang central Hospital

Xinyang, , China

Site Status

The Affiliated Hospital of xuzhou Medical University

Xuzhou, , China

Site Status

Yantai yuhuangding Hospital

Yantai, , China

Site Status

Henan Cancer Hospital

Zhengzhou, , China

Site Status

Countries

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China

Other Identifiers

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JS001-042-III-ESCC

Identifier Type: -

Identifier Source: org_study_id

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