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Although unprecedented advances have been made in the field of esophageal cancer in recent decades, the prognosis for patients with locally advanced esophageal squamous cell carcinoma (ESCC) remains extremely poor, accounting for 30-40% of overall survival at 5 year. In recent years, multimodal treatments have proven to be an appropriate therapeutic approach for locally advanced ESCC. Recently, immunotherapy developed rapidly. The purpose of this study was to observe the efficacy and safety of cardonilizumab combined with chemoradiotherapy in the treatment of locally advanced ESCC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inductive chemoimmunotherapy+chemoradiotherapy±surgery | Experimental | In this group, the patients were given 2 cycles of inductive therapy of cardonilizumab combined with chemotherapy, followed by concurrent chemoradiotherapy with two cycles of nab-paclitaxel and cisplatin plus radiotherapy of 50-50.4 Gy. After clinical evaluation, surgery was feasible for a part of patients. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardonilizumab | Drug | Two cycles of Inductive therapy: nab-paclitaxel 250mg/ m2+cisplatin 75mg/ m2+Cardonilizumab 10mg/kg,ivgtt,3 weeks per cycle for 2 cycles |
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| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival | Time from treatment initiation to locoregional or distant recurrence, or death from any cause. | 1-year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The 1-year OS rate was defined as the proportion of patients who still alive within one year from treatment initiation. | 1-year |
| Adverse events | In terms of adverse events of radiation, chemotherapy and immunotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Wang, M.D. | Contact | +8601087787635 | beryl_wx2000@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xin Wang | Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anyang Cancer Hospital | Not yet recruiting | Anyang | Henan | China |
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| Chemoradiotherapy ±immunotherapy | Radiation | Chemoradiotherapy ± immunotherapy:
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| Radical surgery | Procedure | Surgery was evaluated after concurrent chemoradiotherapy according to patients willing and the surgeons' assessment. If patients were accessed with unresectable disease after radiotherapy or refused to receive surgery, Cardonilizumab would be administered for 2 years or until disease progression. |
|
| 1-year |
| Locoregional recurrence free survival | The 1-year rate was defined as the proportion of patients who did not have any locoregional recurrence from treatment initiation. | 1-year |
| Distant metastasis free survival | The 1-year rate was defined as the proportion of patients who did not have any distant metastasis from treatment initiation. | 1-year |
| The First Affiliated Hospital of Xinxiang Medical University | Not yet recruiting | Xinxiang | Henan | China |
|
| Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) | Recruiting | Beijing | 100021 | China |
|
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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