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To evaluate the safety and feasibility of DCF combined with camrelizumab in the treatment of locally advanced ESCC
Primary outcome:
To evaluate the safety and feasibility of DCF combined with camrelizumab in the treatment of locally advanced ESCC
Secondary outcome:
pathologic complete response (pCR)、Major Pathologic Response(MPR)、R0 resection rate、Objective response rate(ORR)、Disease free survival(DFS)、Relief rate and safety of dysphagia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The experimental group | Experimental | Drug:DCF+Camrelizumab Camrelizumab:200mg/time,IV,Q3W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab 200mg IV D1,Q3W,and preoperative therapy with three cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Feasibility(Incidence of Treatment-Emergent Adverse Events) | All participants with treatment-related adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Event,Version 5.0(CTC AE5.0). | 12months |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response (PCR) | PCR is defined as pT0N0M0 | 1 month after resection |
| Major pathologic response (MPR) | MPR is defined as viable tumor comprised ≤ 10% of resected tumor specimens. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianjun Yang, Dr. | Contact | 0086-13572533693 | Jianjunyang66@hotmail.com | |
| Guanghui Xu, Dr. | Contact | 0086-17791826711 | xuguanghui8@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianjun Yang | Xijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Recruiting | Xi'an | Shaanxi | 710000 | China |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
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Patients fulfilling Eligibility Criteria will be included in our study.After three cycles of resectable esophageal cancer treated with DCF combined with camrelizumab neoadjuvant therapy, the researchers determined whether the patient should undergo surgical treatment according to clinical diagnosis and patient willingness.If the patient underwent surgery, surgery was performed 6-8 weeks after discontinuation;If the patient did not receive surgical treatment, the patient was continued to receive 3 cycles of adjuvant therapy with camrelizumab combined with DCF regimen
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| DCF | Drug | DCF:Oxaliplatin (85mg/ m^2, IV D1,Q3W.Docetaxel: 60 mg/m^2 intravenous infusion for 60 minutes, D1,Q3W.Tegafur:BSA<1.25^2,40 mg/time,1.25^2\ |
|
| 1 month after resection |
| Disease Free Survival (DFS) | Percentage of Participants With DFS, as Assessed by RECIST 1.1. DFS is defined as the time from randomization to the first documented disease progression of local recurrence or distant metastasis or death due to any cause. | 3 and 5 years |