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| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
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The aim of this study was to investigate the safety and efficacy of SHR-1210 in combination with the anti-vascular survival target drug apatinib in patients with resectable NSCLC, and to provide new treatment options for neoadjuvant therapy in patients with the period IB-IIIA NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib Combined With SHR-1210 Injection | Experimental |
The patient underwent imaging examinations within 7 days prior to surgery, including chest CT and related metastatic examinations. The patient underwent surgery 7-8 weeks after the first dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | Apatinib Mesylate Tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major pathologic response rate(MPR)(<10% viable tumor cells) | To assess the major pathologic response rate (<10% viable tumor cells) in patients receiving Apatinib Combined With SHR-1210 Injection. | At time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | the proportion of patients with a best overall response of CR, PR or SD in the whole body, as assessed per RECIST 1.1 by the investigator. | up to 2 years |
| Overall response rate (ORR) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of irAEs | Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE V5.0) | up to 2 years |
| Incidence of SAEs | Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE V5.0) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Li, MD | Contact | +8613880276636 | dr.lijuan@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Juan Li, MD | Sichuan Cancer Hospital and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Cancer Hospital | Chengdu | Sichuan | 610041 | China |
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| SHR-1210 | Drug | Camrelizumab for Injection |
|
|
the proportion of patients with a best overall confirmed response of CR or PR in the whole body as assessed per RECIST 1.1 by the investigator
| up to 2 years |
| Disease-free survival (DFS) | Defined as the time from date of surgery until recurrence of tumor or death from any cause | up to 2 years |
| up to 2 years |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D009369 | Neoplasms |
| D012140 | Respiratory Tract Diseases |
| D013899 | Thoracic Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C553458 | apatinib |
| C000631724 | camrelizumab |
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