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This study is a single-arm prospective clinical trial. The primary objective of the study is to explore the efficacy and safety of preoperative neoadjuvant therapy with Tislelizumab combined with Anlotinib and Nab-Paclitaxel in resectable stage III non-small cell lung cancer.Finally, it provides new evidence-based medical evidence for the perioperative treatment of non-small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment arm | Experimental | Participants received 3-4 cycles of Tislelizumab combined with anlotinib and nab-paclitaxel treatment, once every 3 weeks, for a maximum of 4 cycles. Patients who meet the surgical conditions will undergo surgery within 4 to 6 weeks after neoadjuvant therapy. After the operation, the patient entered the stage of single-agent adjuvant therapy with tislelizumab. The adjuvant therapy with tislelizumab lasted for one year (including preoperative treatment medication, a total of 17 cycles) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neoadjuvant therapy | Drug | tislelizumab (200mg,iv, q3w) + Anlotinib (10mg, orally, D1-14, q3w)+nab-paclitaxel(260mg/m2,q3w)3-4cycle |
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| Measure | Description | Time Frame |
|---|---|---|
| pathological complete response (pCR) | pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy. | Up to approximately 8 weeks following completion of neoadjuvant treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Major Pathological Response (mPR) Rate | mPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy. | Up to approximately 8 weeks following completion of neoadjuvant treatment |
| R0 resection rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanguo Liu | Contact | 18560081902 | liuyanguo@sdu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | China |
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| Surgery | Procedure | Surgery should be performed 4 to 6 weeks after the last neoadjuvant therapy (at least 4 weeks after the end of anlotinib treatment). |
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| Adjuvant therapy | Drug | Tislelizumab: 200mg, iv, Q3W, 1year at most(including preoperative treatment medication, a total of 17 cycles). |
|
R0 Resection Rate: The pathological results will showed that the incision margin was negative and no residual cancer cells were found under the microscope. |
| usually 1 week after surgery |
| Event-Free Survival(EFS) | The time from the start of randomization (or the start of treatment in a one-arm trial) to the first occurrence of any of the following events: disease progression without surgical treatment, local or distant recurrence, death from any cause, etc. | Up to 2years |
| overall survival(OS) | Time from randomization to death (from any cause) | 3 years |
| Safety and Tolerability | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Up to 3 years |
| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| D013514 | Surgical Procedures, Operative |
| D017024 | Chemotherapy, Adjuvant |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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