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This study aims to explore the efficacy and safety of radiotherapy combined with immunotherapy in the neoadjuvant treatment of resectable NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tislelizumab plus radiotherapy | Experimental | Tislelizumab IV 200mg, d1, Q3W; concurrently combined with 40Gy/20f radiotherapy (3D-CRT/IMRT, IMRT, targeting only the lesion and positive lymph nodes), for 3-4 cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | 200mg, iv, Q3W, 3-4 cycle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| pCR rate | Complete pathological response (pCR), defined as the proportion of patients in the ITT analysis set and surgical population analysis set who have no residual tumor in the resected primary tumor and metastatic lymph nodes as assessed by the investigator after the completion of neoadjuvant therapy. Patients who do not meet these criteria, including those who do not undergo surgical resection, will be considered non-responders. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| MPR Rate | Major pathological response (MPR) was defined as the proportion of patients in the ITT analysis set and surgical population analysis set with ≤ 10% residual viable tumor cells in the resected primary tumor and metastatic lymph nodes after the completion of neoadjuvant therapy as assessed by the investigator. Patients who do not undergo surgical resection for reasons such as disease progression will be considered non-responders. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Buhai Wang | Contact | +8651487373012 | wbhself@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Northern People Hospital | Recruiting | Yangzhou | Jiangsu | 225001 | China |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
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| 3D-CRT/IMRT |
| Radiation |
40Gy in 20 fractions |
|
| 18 months |
| 1-year EFS Rate | 1-year EFS rate is defined as the proportion of patients who have not experienced radiographic disease progression, local recurrence or distant metastasis, or death due to any cause assessed by the investigator according to RECIST 1.1 Version, from enrollment to 1 year in the intent-to-treat (ITT) analysis set. The 1-year EFS rate is evaluated by the Kaplan-Meier (KM) method. | Baseline up to 1 years |