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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Active Comparator | Toripalimab combined with cisplatin and paclitaxel |
|
| Control Group | Placebo Comparator | Placebo combined with cisplatin and paclitaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toripalimab combined with cisplatin and paclitaxel | Combination Product | Specified doses on specified days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 |
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Patients must fulfill all of the following inclusion criteria to be eligible for enrollment in this study:
Patients must not enter this study if any of the following exclusion criteria is fulfilled:
Other protocol defined Inclusion/exclusion criteria could apply.
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| Name | Affiliation | Role |
|---|---|---|
| Lin Shen | Peking University Cancer Hospital & Institute | Principal Investigator |
| Yongtao Han | Sichuan Cancer Hospital and Research Institute | Principal Investigator |
| Yan Zheng | Henan Cancer Hospital | Principal Investigator |
| Keneng Chen | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Firest Affiliated Hospital of bengbu Medical College | Bengbu | Anhui | China | |||
| Anhui provincial hospital |
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| Placebo combined with cisplatin and paclitaxel | Combination Product | Specified doses on specified days. |
|
| 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. | 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 |
| 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. | 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 |
| 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 | from randomization to death from any cause at 1 year |
| 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 | from randomization to death from any cause at 3 year |
| 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 | from randomization to death from any cause at 5 year |
| Hefei |
| Anhui |
| 230001 |
| China |
| The Second Hospital of anhui Medical University | Hefei | Anhui | China |
| Jiangmen central Hospital | Jiangmen | Guangdong | China |
| Shenzhen people's hosptial | Shenzhen | Guangdong | 518040 | China |
| The fourth hospital of hebei medical university | Shijiazhuang | Hebei | 050019 | China |
| Anyang Cancer Hospital | Anyang | Henan | China |
| The First Affiliated Hospital of xinxiang Medical University | Xinxiang | Henan | China |
| Henan provincial pepples hospital | Zhengzhou | Henan | 450003 | China |
| The first affilated hospital of zhengzhou university | Zhengzhou | Henan | 450052 | China |
| Hunan provincial cancer hospital | Changsha | Hunan | 410013 | China |
| China-Japan Union hosptial of Jilin university | Changchun | Jilin | 130031 | China |
| The first affiliated hospital of jinzhou medical university | Jinzhou | Niaoning | 121001 | China |
| Shanxi provincial cancer hosptial | Taiyuan | Shanxi | 030013 | China |
| Affiliated Tumor Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | China |
| Hwa Mei Hospital,University of Chinese Academy of sciences | Ningbo | Zhejiang | 315010 | China |
| Taizhou hospital of zhejiang province | Taizhou | Zhejiang | 317000 | China |
| 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 |
| Renmin Hospital of Wuhan University | Wuhan | China |
| Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology | Wuhan | China |
| The First Affiliated Hospital of Xiamen University | Xiamen | China |
| Zhongshan Hospital Affiliated to Xiamen University | Xiamen | China |
| Xinyang central Hospital | Xinyang | China |
| The Affiliated Hospital of xuzhou Medical University | Xuzhou | China |
| Yantai yuhuangding Hospital | Yantai | China |
| Henan Cancer Hospital | Zhengzhou | China |
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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