Clinical trial NCT04848753: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
Lead sponsor: Shanghai Junshi Bioscience Co., Ltd.
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 663
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: To compare IRC-assessed events-free survival (EFS) in 2 arms
timeFrame: 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 outcomes:
measure: pathologically complete remission (pCR) rate
timeFrame: 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
measure: Investigator-assessed EFS according to RECIST v1.1
timeFrame: 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
measure: Overall survival
timeFrame: 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
measure: 1-year OS rate
timeFrame: from randomization to death from any cause at 1 year
measure: 3- year OS rate
timeFrame: from randomization to death from any cause at 3 year
measure: 5- year OS rate
timeFrame: from randomization to death from any cause at 5 year
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The Firest Affiliated Hospital of bengbu Medical College
state: Anhui
city: Hefei
country: China
facility: Anhui provincial hospital
state: Anhui
city: Hefei
country: China
facility: The Second Hospital of anhui Medical University
state: Anhui
city: Jiangmen
country: China
facility: Jiangmen central Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen people's hosptial
state: Guangdong
city: Shijiazhuang
country: China
facility: The fourth hospital of hebei medical university
state: Hebei
city: Anyang
country: China
facility: Anyang Cancer Hospital
state: Henan
city: Xinxiang
country: China
facility: The First Affiliated Hospital of xinxiang Medical University
state: Henan
city: Zhengzhou
country: China
facility: Henan provincial pepples hospital
state: Henan
city: Zhengzhou
country: China
facility: The first affilated hospital of zhengzhou university
state: Henan
city: Changsha
country: China
facility: Hunan provincial cancer hospital
state: Hunan
city: Changchun
country: China
facility: China-Japan Union hosptial of Jilin university
state: Jilin
city: Jinzhou
country: China
facility: The first affiliated hospital of jinzhou medical university
state: Niaoning
city: Taiyuan
country: China
facility: Shanxi provincial cancer hosptial
state: Shanxi
city: Ürümqi
country: China
facility: Affiliated Tumor Hospital of Xinjiang Medical University
state: Xinjiang
city: Ningbo
country: China
facility: Hwa Mei Hospital,University of Chinese Academy of sciences
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou hospital of zhejiang province
state: Zhejiang
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: The General Hospital of People's Liberation Army
city: Changzhi
country: China
facility: Heping Hospital Affiliated to changzhi Medical College
city: Chengdu
country: China
facility: Sichuan Cancer Hospital & Institute
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
city: Hangzhou
country: China
facility: 3201 Hospital
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
city: Hanzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
city: Harbin
country: China
facility: harbin medical university Cancer Hospital
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital
city: Huai'an
country: China
facility: Huai'an First People's Hospital
city: Jining
country: China
facility: The Affiliated Hospital of jining Medical University
city: Nanchang
country: China
facility: The First Affiliated Hospital of nanchang University
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
city: Shantou
country: China
facility: Shantou University Cancer Hospital
city: Shenyang
country: China
facility: Liaoning cancer hospital& Institute
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
city: Shenyang
country: China
facility: The first Hospital of china Medical University
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
city: Wuhan
country: China
facility: Hubei Cancer Hospital
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
city: Wuhan
country: China
facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
city: Xiamen
country: China
facility: Zhongshan Hospital Affiliated to Xiamen University
city: Xinyang
country: China
facility: Xinyang central Hospital
city: Xuzhou
country: China
facility: The Affiliated Hospital of xuzhou Medical University
city: Yantai
country: China
facility: Yantai yuhuangding Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Lin Shen
role: PRINCIPAL_INVESTIGATOR
affiliation: Sichuan Cancer Hospital and Research Institute
name: Yongtao Han
role: PRINCIPAL_INVESTIGATOR
affiliation: Henan Cancer Hospital
name: Yan Zheng
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Cancer Hospital & Institute
name: Keneng Chen
role: PRINCIPAL_INVESTIGATOR
References: