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A prospective, single arm, single center, phase II clinical trial of neoadjuvant chemotherapy with camrelizumab in locally advanced esophageal squamous cell,to evaluate the progression free survival
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neoadjuvant chemotherapy with camrelizumab | Experimental | paclitaxel and cisplatin Carilizumab 200 mg, every 3 weeks, 2 cycles. Paclitaxel 175 mg / m2, D1, every 3 weeks, 2 cycles Cisplatin 75mg / m2 D1, conventional hydration for 3 days, every 3 weeks, 2 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| camrelizumab | Drug | Carilizumab 200 mg, every 3 weeks, 2 cycles.Paclitaxel 175 mg / m2, D1, every 3 weeks, 2 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response rate (pCR) | Pathological complete response rate | from the first cycle of treatment (day one) to two month after the last cycle (each cycle is 21 days) |
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Inclusion Criteria:
1. The age ranged from 18 to 75 years 2. Middle or lower thoracic esophageal carcinoma 3. Gastroscopy showed squamous cell carcinoma 4. The clinical stage was c-txn1-3m0 5. ECOG score was 0-1 6. Can eat semifluid 7. Weight loss less than 20% in 6 months 8. Sign the consent form before treatment 9. One week before enrollment, the organ function level reached the following standards:
Exclusion Criteria:
1) Have received anti-PD-1 or anti-PD-L1 antibody treatment in the past; 2) Received any research drug within 4 weeks before the first use of the study drug; 3) At the same time, they were enrolled in another clinical study, unless it was an observational (non intervention) clinical study or an intervention clinical study follow-up; 4) Have received any anti-tumor treatment related to esophageal cancer, including but not limited to radiotherapy, chemotherapy, surgery, ESD, EMR, immunotherapy, targeted therapy, and traditional Chinese medicine treatment; 5) Subjects who needed systemic treatment with corticosteroids (10 mg prednisone equivalent dose per day) or other immunosuppressants within 2 weeks before the first use of the study drug were excluded from the use of corticosteroids for local esophageal inflammation and prevention of allergy, nausea and vomiting. Other special circumstances, need to communicate with the sponsor. In the absence of active autoimmune disease, inhaled or topical corticosteroids and corticosteroids with dose > 10 mg / day prednisone were allowed to be used instead; 6) Those who have received anti-tumor vaccine or received live vaccine within 4 weeks before the first administration of the study drug; 7) Major surgery or severe trauma occurred within 4 weeks before the first use of the study drug; 17. History of congenital or acquired immunodeficiency disease or organ transplantation; 18. He had a history of allergy to monoclonal antibodies, paclitaxel, cisplatin and other platinum drugs;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| wang jia lei, doctor | Contact | 18017312369 | haitunqiao@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer hospital Fudan University | Recruiting | Shanghai | Xuhui | 200032 | China |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D017239 | Paclitaxel |
| D002945 | Cisplatin |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Paclitaxel | Drug | Cisplatin 75mg / m2 D1, conventional hydration for 3 days, every 3 weeks, 2 cycles |
|
| Neoadjuvant Chemotherapy | Drug | Neoadjuvant Chemotherapy |
|
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |