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

Primary Purpose

Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Toripalimab combined with cisplatin and paclitaxel
Placebo combined with cisplatin and paclitaxel
Sponsored by
Shanghai Junshi Bioscience Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The Firest Affiliated Hospital of bengbu Medical College
  • Anhui provincial hospital
  • The Second Hospital of anhui Medical University
  • Jiangmen central Hospital
  • Shenzhen people's hosptial
  • The fourth hospital of hebei medical university
  • Anyang Cancer Hospital
  • The First Affiliated Hospital of xinxiang Medical University
  • Henan provincial pepples hospital
  • The first affilated hospital of zhengzhou university
  • Hunan provincial cancer hospital
  • China-Japan Union hosptial of Jilin university
  • The first affiliated hospital of jinzhou medical university
  • Shanxi provincial cancer hosptial
  • Affiliated Tumor Hospital of Xinjiang Medical University
  • Hwa Mei Hospital,University of Chinese Academy of sciences
  • Taizhou hospital of zhejiang province
  • Beijing Cancer Hospital
  • Peking University Third Hospital
  • The General Hospital of People's Liberation Army
  • Heping Hospital Affiliated to changzhi Medical College
  • Sichuan Cancer Hospital & Institute
  • Fujian Cancer Hospital
  • 3201 Hospital
  • Zhejiang Cancer Hospital
  • The First Affiliated Hospital, Zhejiang University School of Medicine
  • harbin medical university Cancer Hospital
  • Anhui Provincial Cancer Hospital
  • Huai'an First People's Hospital
  • The Affiliated Hospital of jining Medical University
  • The First Affiliated Hospital of nanchang University
  • Jiangsu Cancer Hospital
  • The Affiliated Hospital of Qingdao University
  • Zhongshan Hospital Fudan University
  • Shantou University Cancer Hospital
  • Liaoning cancer hospital& Institute
  • Shengjing Hospital of China Medical University
  • The first Hospital of china Medical University
  • Tianjin Medical University Cancer Institute and Hospital
  • Hubei Cancer Hospital
  • Renmin Hospital of Wuhan University
  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
  • The First Affiliated Hospital of Xiamen University
  • Zhongshan Hospital Affiliated to Xiamen University
  • Xinyang central Hospital
  • The Affiliated Hospital of xuzhou Medical University
  • Yantai yuhuangding Hospital
  • Henan Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Experimental Group

Control Group

Arm Description

Toripalimab combined with cisplatin and paclitaxel

Placebo combined with cisplatin and paclitaxel

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

pathologically complete remission (pCR) rate
To compare the percentage of patients who achieved pCR in the 2 arms, pCR rate was defined as the percentage of subjects who achieved a complete pathological response (PCR)
Investigator-assessed EFS according to RECIST v1.1
To compare Investigator-assessed events-free survival (EFS) in 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.
Overall survival
To compare Overall survival in 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.
1-year OS rate
To compare 1-year OS rates in 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
3- year OS rate
To compare 3-year OS rates in 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
5- year OS rate
To compare 5-year OS rates in 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

Full Information

First Posted
April 9, 2021
Last Updated
July 19, 2023
Sponsor
Shanghai Junshi Bioscience Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04848753
Brief Title
Perioperative Toripalimab (JS001) Combined With Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 23, 2021 (Actual)
Primary Completion Date
May 12, 2027 (Anticipated)
Study Completion Date
May 12, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Junshi Bioscience Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
663 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Active Comparator
Arm Description
Toripalimab combined with cisplatin and paclitaxel
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Placebo combined with cisplatin and paclitaxel
Intervention Type
Combination Product
Intervention Name(s)
Toripalimab combined with cisplatin and paclitaxel
Intervention Description
Specified doses on specified days.
Intervention Type
Combination Product
Intervention Name(s)
Placebo combined with cisplatin and paclitaxel
Intervention Description
Specified doses on specified days.
Primary Outcome Measure Information:
Title
To compare IRC-assessed events-free survival (EFS) in 2 arms
Time Frame
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
Secondary Outcome Measure Information:
Title
pathologically complete remission (pCR) rate
Description
To compare the percentage of patients who achieved pCR in the 2 arms, pCR rate was defined as the percentage of subjects who achieved a complete pathological response (PCR)
Time Frame
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
Title
Investigator-assessed EFS according to RECIST v1.1
Description
To compare Investigator-assessed events-free survival (EFS) in 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.
Time Frame
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
Title
Overall survival
Description
To compare Overall survival in 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.
Time Frame
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
Title
1-year OS rate
Description
To compare 1-year OS rates in 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
Time Frame
from randomization to death from any cause at 1 year
Title
3- year OS rate
Description
To compare 3-year OS rates in 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
Time Frame
from randomization to death from any cause at 3 year
Title
5- year OS rate
Description
To compare 5-year OS rates in 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
Time Frame
from randomization to death from any cause at 5 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 exclusion criteria 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Shen
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yongtao Han
Organizational Affiliation
Sichuan Cancer Hospital & Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yan Zheng
Organizational Affiliation
Henan Cancer Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Keneng Chen
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Firest Affiliated Hospital of bengbu Medical College
City
Bengbu
State/Province
Anhui
Country
China
Facility Name
Anhui provincial hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
The Second Hospital of anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Facility Name
Jiangmen central Hospital
City
Jiangmen
State/Province
Guangdong
Country
China
Facility Name
Shenzhen people's hosptial
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518040
Country
China
Facility Name
The fourth hospital of hebei medical university
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050019
Country
China
Facility Name
Anyang Cancer Hospital
City
Anyang
State/Province
Henan
Country
China
Facility Name
The First Affiliated Hospital of xinxiang Medical University
City
Xinxiang
State/Province
Henan
Country
China
Facility Name
Henan provincial pepples hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Facility Name
The first affilated hospital of zhengzhou university
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Hunan provincial cancer hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
China-Japan Union hosptial of Jilin university
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130031
Country
China
Facility Name
The first affiliated hospital of jinzhou medical university
City
Jinzhou
State/Province
Niaoning
ZIP/Postal Code
121001
Country
China
Facility Name
Shanxi provincial cancer hosptial
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030013
Country
China
Facility Name
Affiliated Tumor Hospital of Xinjiang Medical University
City
Ürümqi
State/Province
Xinjiang
Country
China
Facility Name
Hwa Mei Hospital,University of Chinese Academy of sciences
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China
Facility Name
Taizhou hospital of zhejiang province
City
Taizhou
State/Province
Zhejiang
ZIP/Postal Code
317000
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Facility Name
The General Hospital of People's Liberation Army
City
Beijing
Country
China
Facility Name
Heping Hospital Affiliated to changzhi Medical College
City
Changzhi
Country
China
Facility Name
Sichuan Cancer Hospital & Institute
City
Chengdu
Country
China
Facility Name
Fujian Cancer Hospital
City
Fuzhou
Country
China
Facility Name
3201 Hospital
City
Hangzhou
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
Country
China
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine
City
Hanzhou
Country
China
Facility Name
harbin medical university Cancer Hospital
City
Harbin
Country
China
Facility Name
Anhui Provincial Cancer Hospital
City
Hefei
Country
China
Facility Name
Huai'an First People's Hospital
City
Huai'an
Country
China
Facility Name
The Affiliated Hospital of jining Medical University
City
Jining
Country
China
Facility Name
The First Affiliated Hospital of nanchang University
City
Nanchang
Country
China
Facility Name
Jiangsu Cancer Hospital
City
Nanjing
Country
China
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
Country
China
Facility Name
Shantou University Cancer Hospital
City
Shantou
Country
China
Facility Name
Liaoning cancer hospital& Institute
City
Shenyang
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
Country
China
Facility Name
The first Hospital of china Medical University
City
Shenyang
Country
China
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
Country
China
Facility Name
Hubei Cancer Hospital
City
Wuhan
Country
China
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
Country
China
Facility Name
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
Country
China
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
Country
China
Facility Name
Zhongshan Hospital Affiliated to Xiamen University
City
Xiamen
Country
China
Facility Name
Xinyang central Hospital
City
Xinyang
Country
China
Facility Name
The Affiliated Hospital of xuzhou Medical University
City
Xuzhou
Country
China
Facility Name
Yantai yuhuangding Hospital
City
Yantai
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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