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This study is an open-label, prospective, cohort clinical study to evaluate the safety and efficacy of different cycles of sintilimab in combination with platinum-containing chemotherapy as preoperative neoadjuvant therapy in patients with resectable esophageal cancer. In the study, all subjects who meet the enrollment criteria will be randomized 1:1:1 to receive sintilimab combined with platinum-containing chemotherapy Q3W for 3 cycles (Group A), sintilimab combined with platinum-containing chemotherapy Q3W for 2 cycles + sintilimab for 1 cycle (Group B), sintilimab combined with platinum-containing chemotherapy for 1 cycle + sintilimab Q3W for 2 cycles (Group B) as neoadjuvant therapy, and receive radical surgery within 4-6 weeks after the completion of the last neoadjuvant therapy. Whether the subjects need adjuvant therapy and adjuvant treatment regimen after surgery are determined by the investigator, and all subjects need to complete the follow-up plan formulated by the study after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | sintilimab combined with platinum-containing chemotherapy Q3W for 3 cycles |
| |
| Group B | sintilimab combined with platinum-containing chemotherapy Q3W for 2 cycles + sintilimab for 1 cycle |
| |
| Group C | sintilimab combined with platinum-containing chemotherapy for 1 cycle + sintilimab Q3W for 2 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab (PD-1 inhibitor) | Drug | to evaluate the safety and efficacy of different cycles of sintilimab in combination with platinum-containing chemotherapy as preoperative neoadjuvant therapy in patients with resectable esophageal cancer. |
| Measure | Description | Time Frame |
|---|---|---|
| complete pathologic response (pCR) | no residual tumor cells in the surgically resected tumor specimen and all sampled regional lymph nodes after neoadjuvant treatment. | 3 mouths |
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Inclusion Criteria:
Exclusion Criteria:
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This study is an open-label, prospective, cohort clinical study to evaluate the safety and efficacy of different cycles of sintilimab in combination with platinum-containing chemotherapy as preoperative neoadjuvant therapy in patients with resectable esophageal cancer
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tangdu Hospital of the Fourth Millitary Medical University | Xi'an | Shaanxi | 710000 | China |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
| D000082082 | Immune Checkpoint Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
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| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |