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This is a multicenter phase II clinical study to explore the efficacy, safety, and organ preservation feasibility of camrelizumab in combination with chemotherapy for resectable esophageal squamous carcinoma in patients with histologically and pathologically confirmed resectable esophageal squamous carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab+chemotherapy | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab + Nab-paclitaxel + Cisplatin | Drug | Three cycles of neoadjuvant therapy with camrelizumab (200 mg/dose D1, IV, Q3W)+Nab-paclitaxel(260 mg/m2 D1,IV,Q3W)+Cisplatin(75 mg/m2 D1,IV,Q3W); for patients with organ preservation intent entered into the watchful waiting strategy group and received radiotherapy (50.4 Gy/28 doses), with camrelizumab maintenance therapy for 4-12 weeks after the end of radiotherapy, and a total of up to one year of camrelizumab. |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival (EFS) | The length of time between signing the informed consent form and the occurrence of any of the following events: disease progression, disease recurrence, or death from any cause | about 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical complete remission (cCR) rate | Defined as the proportion of subjects who achieved CR as assessed according to RECIST 1.1 and whose endoscopic biopsies were free of residual tumor; | about 2 years |
| Pathologic complete remission (pCR) rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital | Recruiting | Beijing | 100142 | China |
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Defined as no residual tumor cells after evaluation of the resected tumor tissue and regional lymph.
| about 2 years |
| Progression-free survival (PFS) in subjects with organ preservation strategies | From the time of dosing until tumor recurrence, including local recurrence or distant metastasis or death from any cause, based on imaging evaluation or tissue biopsy evidence, whichever occurs first; | about 2 years |
| Overall survival (OS) in subjects with organ preservation strategies | Time from administration to death from any cause | about 2 years |
| Adverse Events (AE) | Incidence and grade (including serious adverse events and immunization-related adverse events), as determined by NCI-CTCAE 5.0 criteria | about 2 years |
| 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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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C520255 | 130-nm albumin-bound paclitaxel |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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