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The purpose of this study is to observe and evaluate the efficacy and safety of camrelizumab combined with albumin paclitaxel and cisplatin as perioperative treatment of advanced esophageal squamous cell.
The incidence of esophageal cancer is ranked seventh in the world, and the mortality rate ranks sixth in the world. Surgical treatment of early esophageal cancer has a good prognosis, and advanced esophageal cancer often requires a combination of surgery, chemotherapy, radiotherapy and immunotherapy, but the prognosis is still poor. The investigators designed a randomized, controlled, phase II study of perioperative camrelizumab combined with albumin paclitaxel and cisplatin in patients with resectable esophageal squamous cell carcinoma. The purpose of this study is to observe and evaluate the efficacy and safety of camrelizumab combined with albumin paclitaxel and cisplatin as perioperative treatment of advanced esophageal squamous cell.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| After 2 cycles of neoadjuvant therapy,non-pCR patients adjuvant treatment | Experimental | After 2 cycles of neoadjuvant therapy(Camrelizumab+Albumin Paclitaxel+Cisplatin), non-pCR patients adjuvant treatment(2-4 cycles Camrelizumab+Albumin Paclitaxel +Cisplatin and Camrelizumab maintenance treatment) |
|
| non-pCR patients adjuvant treatment | Active Comparator | After 2 cycles of neoadjuvant therapy(Camrelizumab+Albumin Paclitaxel+Cisplatin), non-pCR patients adjuvant treatment(Camrelizumab maintenance treatment) |
|
| pCR patients adjuvant treatment | Experimental | After 2 cycles of neoadjuvant therapy(Camrelizumab+Albumin Paclitaxel+Cisplatin), pCR patients adjuvant treatment(Camrelizumab maintenance treatment) |
|
| pCR patients adjuvant treatment(BSC) | Active Comparator | After 2 cycles of neoadjuvant therapy(Camrelizumab+Albumin Paclitaxel+Cisplatin), pCR patients adjuvant treatment(Best Supportive Care) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A:non-pCR patients | Drug | After 2 cycles of neoadjuvant therapy(Camrelizumab+Albumin Paclitaxel+Cisplatin), non-pCR patients adjuvant treatment(2-4 cycles Camrelizumab+Albumin Paclitaxel+Cisplatin and Camrelizumab maintenance treatment) Camrelizumab, 200 mg,Intravenous injection,q3W continuous medication Albumin Paclitaxel, 125 mg/m2, Intravenous injection d1,8 q3W continuous medication Cisplatin: 75mg/m2, Intravenous injection,d1, q3W continuous medication |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic complete response,pCR | defined as the absence of any viable tumor at the time of surgical resection, as assessed by central and local pathology laboratory | At time of surgery |
| 3 years disease free survival, DFS | Time after R0 resection to disease recurrence or death | up to 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| Major pathological response(MPR) | defined as ≤ 10% residual viable tumor at the time of surgical resection, as assessed by central pathology laboratory. | At time of surgery |
| Objective Response Rate (ORR) |
| Measure | Description | Time Frame |
|---|---|---|
| The exploration of biomarkers | Exploring circulating tumor cells and circulating tumor DNA in neoadjuvant immunotherapy and adjuvant therapy for esophageal squamous cell carcinoma application value in immunotherapy. | up to 2 year |
Inclusion Criteria:-
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Song Zhao | Contact | 13673665008 | zhaosong@zzu.cn | |
| Yu Qi | Contact | 13803892392 | qiyu@zzu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Song Zhao | The First Affiliated Hospital of Zhengzhou University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| B:non-pCR patients | Drug | After 2 cycles of neoadjuvant therapy(Camrelizumab+Albumin Paclitaxel+Cisplatin), non-pCR patients adjuvant treatment(Camrelizumab maintenance treatment) Camrelizumab, 200 mg,Intravenous injection,q3W continuous medication Albumin Paclitaxel, 125 mg/m2, Intravenous injection d1,8 q3W continuous medication Cisplatin: 75mg/m2, Intravenous injection,d1, q3W continuous medication |
|
| A:pCR patients | Drug | After 2 cycles of neoadjuvant therapy(Camrelizumab+Albumin Paclitaxel+Cisplatin), pCR patients adjuvant treatment(Camrelizumab maintenance treatment) Camrelizumab, 200 mg,Intravenous injection,q3W continuous medication Albumin Paclitaxel, 125 mg/m2, Intravenous injection d1,8 q3W continuous medication Cisplatin: 75mg/m2, Intravenous injection,d1, q3W continuous medication |
|
| B:pCR patients | Drug | After 2 cycles of neoadjuvant therapy(Camrelizumab+Albumin Paclitaxel+Cisplatin), pCR patients adjuvant treatment(Best Supportive Care) Camrelizumab, 200 mg,Intravenous injection,q3W continuous medication Albumin Paclitaxel, 125 mg/m2, Intravenous injection d1,8 q3W continuous medication Cisplatin: 75mg/m2, Intravenous injection,d1, q3W continuous medication |
|
CR( complete response)+PR(partial response)
| up to 2 year |
| Disease-Free Survival (DFS) | Time after R0 resection to disease recurrence or death | up to 5 year |
| Overall Survival (OS) | defined as the time from randomization to death from any cause during the course of the study. | up to 5 year |
| European Organisation for Research and Treatment of Cancer (EORTC) Multi-trait scaling analyses and face validity refined the module to four scales and six single items (QLQ-OES18). | EORTC QLQ-OES18 | up to 5 year |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |