Perioperative Toripalimab (JS001) Combined With Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

NCT04848753 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Junshi Bioscience Co., Ltd.

Phase

Phase 3

Started

2021-05-12

Last updated

2026-04-08

Condition(s) studied

Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

Toripalimab combined with cisplatin and paclitaxelPlacebo combined with cisplatin and paclitaxel

Toripalimab combined with cisplatin and paclitaxel: Specified doses on specified days.

Placebo combined with cisplatin and paclitaxel: Specified doses on specified days.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Patients must fulfill all of the following inclusion criteria to be eligible for enrollment in this study: 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. Patients must not enter this study if any of the following exclusion criteria is fulfilled: 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. Other protocol defined Inclusion/exclusion criteria could apply.

Primary outcome measure(s)

To compare IRC-assessed events-free survival (EFS) in 2 arms — 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

Trial sites (48)

Facility	City	Region
The Firest Affiliated Hospital of bengbu Medical College	Bengbu	Anhui
Anhui provincial hospital	Hefei	Anhui
The Second Hospital of anhui Medical University	Hefei	Anhui
Jiangmen central Hospital	Jiangmen	Guangdong
Shenzhen people's hosptial	Shenzhen	Guangdong
The fourth hospital of hebei medical university	Shijiazhuang	Hebei
Anyang Cancer Hospital	Anyang	Henan
The First Affiliated Hospital of xinxiang Medical University	Xinxiang	Henan
Henan provincial pepples hospital	Zhengzhou	Henan
The first affilated hospital of zhengzhou university	Zhengzhou	Henan
Hunan provincial cancer hospital	Changsha	Hunan
China-Japan Union hosptial of Jilin university	Changchun	Jilin
The first affiliated hospital of jinzhou medical university	Jinzhou	Niaoning
Shanxi provincial cancer hosptial	Taiyuan	Shanxi
Affiliated Tumor Hospital of Xinjiang Medical University	Ürümqi	Xinjiang
Hwa Mei Hospital,University of Chinese Academy of sciences	Ningbo	Zhejiang
Taizhou hospital of zhejiang province	Taizhou	Zhejiang
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

+ 8 more sites — see the full list on the official registry below.

More Shanghai Junshi Bioscience Co., Ltd. trials in China

PD1 Combined With Chemotherapy for Adjuvant Treatment of Gastric Cancer Active, not recruiting

Phase II Study of JS212/JS213 as Monotherapy and in Combination in Patients With Advanced Malignant Solid Tumors Recruiting

Efficacy and Safety of JS002 as Monotherapy in Patients With Primary Hypercholesterolaemia and Mixed Dyslipidemia Recruiting

JS203 Combination Regimens in B-Cell Non-Hodgkin's Lymphoma Active, not recruiting

A Study Evaluating the Safety and Efficacy of JS212 Combination Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma Recruiting

Other trials for the same condition

Perioperative Cadonilimab Combined With Neoadjuvant Chemotherapy in Resectable Esophageal Squamous Cell Carcinoma (ESCC) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04848753 on ClinicalTrials.gov ↗ ← All trials in China