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| Name | Class |
|---|---|
| Shanghai Junshi Bioscience Co., Ltd. | OTHER |
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Neoadjuvant Triprizumab and Radiotherapy in Operable Patients With Stage IIA-IIIA Non-small Cell Lung Cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toripalimab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toripalimab | Drug | 200 mg Toripalimab intravenously every 3 weeks 3 doses of Toripalimab before operation 14 doses of Toripalimab 30 days after operation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major pathologic response rates | Major pathological response rates assessed by independent center pathology | 42months |
| Event-free survival | The time from the beginning of enrollment to the occurrence of any events, including death, disease progression, change of chemotherapy regimen, change of chemotherapy, addition of other treatments, the occurrence of fatal or intolerant side effects and other events | 42months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Kaplan-Meier median estimates and curves will be used to describe OS survival functions | 42 months |
| Pathologic complete response (pCR) rates | Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review. |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers | PD-L1 expression of tissue specimens、TMB、WES and changes of ctDNA in peripheral blood | 42 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Buhai, doctor | Contact | 18051062288 | wbhself@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| People's hospital of northern jiangsu | Recruiting | Yangzhou | Jiangsu | 225000 | China |
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| Conventional segmental radiotherapy | Radiation | the does of radiation will be 40-45Gy. The day of the first dose of Toripalimab and the first day of radiation must be the same day. |
|
| opreation | Other | The operable patients will accept radical operated in 28-42 days after the third dose of Toripalimab |
|
| 42months |
| Disease-free survival | Some time until the tumor recurs or die for various reasons | 42 months |
| Number of Participants Experiencing Adverse Events (AEs) and serious adverse events (SAEs) | Adverse events are defined as any adverse medical events that occur in the participants taking the drugs and do not necessarily have a causal relationship with the treatment. AEs/SAEs were evaluated using NCI-CTCAE v5.0 | 42 months |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
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