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The prognosis of locally advanced esophageal squamous cell carcinoma is poor,the role of chemotherapy as neoadjuvant therapy in locally advanced esophageal cancer has been established, which can convert some unresectable esophageal cancer into resectable esophageal cancer.PD-1 antibody has been shown to improve the pathological complete response rate in NSCLC, however, the data in neoadjuvant of esophageal squamous carcinoma is relatively rare. This study was designed to know the value of PD-1 antibody in neoadjuvant therapy of esophageal cancer.
The prognosis of locally advanced esophageal squamous cell carcinoma is poor, the 5-year survival rate is less than 50%. It is necessary to conduct studies in these patients to reduce the rate of postoperative recurrence and prolong the disease-free survival. The role of chemotherapy as neoadjuvant therapy in locally advanced esophageal cancer has been established, which can convert some unresectable esophageal cancer into resectable esophageal cancer. The PD-1 antibody, teripalimab, is an immunological checkpoint inhibitor that has shown clinical efficacy in advanced esophageal cancer, but there has been relatively few data on neoadjuvant therapy. This study was designed to comprehend the pathological complete response rate, disease-free survival, and safety of neoadjuvant therapy with chemotherapy plus teriprilin patients with locally advanced esophageal squamous cell carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | teripalimab 240mg d1 paclitaxel 150-175mg/m2 d1 cisplatin 70-75mg/m2 d1 |
|
| chemotherapy followed by immunotherapy | Active Comparator | paclitaxel 150-175mg/m2 d1 cisplatin 70-75mg/m2 d1 teripalimab 240mg d3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| teripalimab plus chemotherapy | Drug | teripalimab 240mg d1 paclitaxel 150mg/m2 d1 cisplatin 70mg/m2 d1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response rate | the proportion of patients got pathological complete response rate | two months |
| Measure | Description | Time Frame |
|---|---|---|
| occurrence rate of adverse events | the occurrence of adverse events | three month |
| disease-free survival rate | the proportion of patients without relapse |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quanli Gao, Dr. | Contact | +86-15038171966 | gaoquanli2015@126.com | |
| Lingdi Zhao, Dr. | Contact | +86-371-65587483 | lingdizhao@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Ding, Master | Henan Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450008 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34938292 | Derived | Xing W, Zhao L, Zheng Y, Liu B, Liu X, Li T, Zhang Y, Ma B, Yang Y, Shang Y, Fu X, Liang G, Yuan D, Qu J, Chai X, Zhang H, Wang Z, Lin H, Liu L, Ren X, Zhang J, Gao Q. The Sequence of Chemotherapy and Toripalimab Might Influence the Efficacy of Neoadjuvant Chemoimmunotherapy in Locally Advanced Esophageal Squamous Cell Cancer-A Phase II Study. Front Immunol. 2021 Dec 6;12:772450. doi: 10.3389/fimmu.2021.772450. eCollection 2021. | |
| 33282388 |
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| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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patients with local advanced esophageal squamous cell carcinoma receive two cycle of neoadjuvant chemotherapy and PD-1 antibody in the same day or chemotherapy followed by PD-1 antibody, and then surgery
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| chemotherapy plus teripalimab | Drug | paclitaxel 150mg/m2 d1 cisplatin 70mg/m2 d1 teripalimab 240mg d3 |
|
|
| three years |
| Derived |
| Xing W, Zhao L, Fu X, Liang G, Zhang Y, Yuan D, Li Z, Gao Q, Zheng Y; written on Henan Cancer Hospital Thoracic Oncology Group (HCHTOG). A phase II, single-centre trial of neoadjuvant toripalimab plus chemotherapy in locally advanced esophageal squamous cell carcinoma. J Thorac Dis. 2020 Nov;12(11):6861-6867. doi: 10.21037/jtd-20-2198. |
| D018307 |
| Neoplasms, Squamous Cell |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |