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This is a single-arm, open, exploratory clinical study to evaluate the efficacy and safety of camrelizumab combined with chemotherapy for adjuvant treatment of nodal positive thoracic esophageal squamous cell carcinoma.
Treatment with carrilizumab combined with chemotherapy was planned for 4 to 6 cycles, after which carrilizumab monotherapy was maintained until disease progression, unacceptable toxicity, or patient withdrawal.
vial card Rayleigh bead sheet resistance: intravenous drip, fixed dose of 200 mg, with 30 minutes to an intravenous drip
(The overall infusion time including the flushing time shall be no less than 20 minutes, no longer than 60 minutes), Day 1, every repeat once every 2 weeks.
paclitaxel: 150 mg/m2, intravenous drip for 30 minutes, 1 day, every 14 days for a cycle.
cisplatin: 50 mg/m2, 2 days, every 14 days for a cycle.
A total of 4 to 6 cycles, after carrilizumab maintenance treatment for one year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | Treatment with camrelizumab combined with chemotherapy was planned for 4 to 6 cycles, after which carrilizumab monotherapy was maintained until disease progression, unacceptable toxicity, or patient withdrawal. A total of 4 to 6 cycles, after carrilizumab maintenance treatment for one year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | Camrelizumab 200mg iv q2w |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 3-year DFS rate | The probability of 3-year disease-free survival | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| DFS | disease-free survival | From date of randomization until the date of first documented progression, assessed up to 60 months |
| 3 years OS rate | The probability of 3-year overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng M Tang, archiater | Contact | 18526812877 | 18526812877@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Peng Tang, archiater | Affiliated Cancer Hospital of Tianjin Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Cancer Hospital of Tianjin Medical University | Recruiting | Tianjin | Tianjin Municipality | 300000 | 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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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D036881 | Long-Term Synaptic Depression |
| D017239 | Paclitaxel |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D009473 | Neuronal Plasticity |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D043823 | Taxoids |
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| Paclitaxel | Drug | 150mg/m² iv d1 q2w |
|
| Cisplatin | Drug | 50 mg/m² iv d2 q2w |
|
| 8 weeks |
| 5 years OS rate | The probability of 5-year overall survival | 8 weeks |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |