Perioperative Toripalimab (JS001) Combined With Neoadjuvant Chemotherapy in Patients With Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
- Conditions
- Resectable Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma
- Interventions
- Combination Product: Placebo combined with cisplatin and paclitaxelCombination Product: Toripalimab combined with cisplatin and paclitaxel
- Registration Number
- NCT04848753
- Lead Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 663
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Control Group Placebo combined with cisplatin and paclitaxel Placebo combined with cisplatin and paclitaxel Experimental Group Toripalimab combined with cisplatin and paclitaxel Toripalimab combined with cisplatin and paclitaxel
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 1-year OS rate from randomization to death from any cause at 1 year 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 from randomization to death from any cause at 3 year 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 from randomization to death from any cause at 5 year 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
pathologically complete remission (pCR) rate 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 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 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 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 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 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.
Trial Locations
- Locations (48)
Shanxi provincial cancer hosptial
π¨π³Taiyuan, Shanxi, China
Peking University Third Hospital
π¨π³Beijing, China
Sichuan Cancer Hospital & Institute
π¨π³Chengdu, China
Anhui provincial hospital
π¨π³Hefei, Anhui, China
The Firest Affiliated Hospital of bengbu Medical College
π¨π³Bengbu, Anhui, China
The Second Hospital of anhui Medical University
π¨π³Hefei, Anhui, China
Anyang Cancer Hospital
π¨π³Anyang, Henan, China
Jiangmen central Hospital
π¨π³Jiangmen, Guangdong, China
The fourth hospital of hebei medical university
π¨π³Shijiazhuang, Hebei, China
Shenzhen people's hosptial
π¨π³Shenzhen, Guangdong, China
Henan provincial pepples hospital
π¨π³Zhengzhou, Henan, China
The First Affiliated Hospital of xinxiang Medical University
π¨π³Xinxiang, Henan, China
Hunan provincial cancer hospital
π¨π³Changsha, Hunan, China
China-Japan Union hosptial of Jilin university
π¨π³Changchun, Jilin, China
The first affilated hospital of zhengzhou university
π¨π³Zhengzhou, Henan, China
The first affiliated hospital of jinzhou medical university
π¨π³Jinzhou, Niaoning, China
Affiliated Tumor Hospital of Xinjiang Medical University
π¨π³ΓrΓΌmqi, Xinjiang, China
Hwa Mei Hospital,University of Chinese Academy of sciences
π¨π³Ningbo, Zhejiang, China
Taizhou hospital of zhejiang province
π¨π³Taizhou, Zhejiang, China
Beijing Cancer Hospital
π¨π³Beijing, China
The General Hospital of People's Liberation Army
π¨π³Beijing, China
Heping Hospital Affiliated to changzhi Medical College
π¨π³Changzhi, China
3201 Hospital
π¨π³Hangzhou, China
Zhejiang Cancer Hospital
π¨π³Hangzhou, China
The First Affiliated Hospital, Zhejiang University School of Medicine
π¨π³Hanzhou, China
Anhui Provincial Cancer Hospital
π¨π³Hefei, China
Huai'an First People's Hospital
π¨π³Huai'an, China
The Affiliated Hospital of jining Medical University
π¨π³Jining, China
harbin medical university Cancer Hospital
π¨π³Harbin, China
The First Affiliated Hospital of nanchang University
π¨π³Nanchang, China
Liaoning cancer hospital& Institute
π¨π³Shenyang, China
The Affiliated Hospital of Qingdao University
π¨π³Qingdao, China
Zhongshan Hospital Fudan University
π¨π³Shanghai, China
Shantou University Cancer Hospital
π¨π³Shantou, China
Tianjin Medical University Cancer Institute and Hospital
π¨π³Tianjin, China
Shengjing Hospital of China Medical University
π¨π³Shenyang, China
The first Hospital of china Medical University
π¨π³Shenyang, China
Hubei Cancer Hospital
π¨π³Wuhan, China
Xinyang central Hospital
π¨π³Xinyang, China
The First Affiliated Hospital of Xiamen University
π¨π³Xiamen, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
π¨π³Wuhan, China
Renmin Hospital of Wuhan University
π¨π³Wuhan, China
Zhongshan Hospital Affiliated to Xiamen University
π¨π³Xiamen, China
The Affiliated Hospital of xuzhou Medical University
π¨π³Xuzhou, China
Yantai yuhuangding Hospital
π¨π³Yantai, China
Henan Cancer Hospital
π¨π³Zhengzhou, China
Jiangsu Cancer Hospital
π¨π³Nanjing, China
Fujian Cancer Hospital
π¨π³Fuzhou, China