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Predicting relapse and overall survival in potentially resectable Stage IIIA-IIIB Non-small Cell Lung Cancer (NSCLC) patients remains challenging. It is now widely recognized that patients with detectable MRD have a worse prognosis than those with undetectable MRD. Therefore, investigators performed this prospective clinical trial to evaluate the predictive value of MRD with increased risk of relapse and improves prediction of outcome in potentially resectable Stage IIIA-IIIB NSCLC with neoadjuvant chemoimmunotherapy. In this study, investigators will pay more attention to the long-term follow-up time and dynamic monitoring of MRD. The predictive value of MRD with Disease-free survival (DFS) rate was observed as the primary endpoint. Besides that, the correlation of MRD with major pathologic response (MPR) rate, pathologic complete response (pCR) rate,event-free survival(EFS) rate and overall survival (OS) were observed as the second endpoints. Investigators hope it will provide a new insight for these potentially resectable Stage IIA-IIIB NSCLC with neoadjuvant chemoimmunotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| immunotherapy and chemotherapy | Participants received two to three cycles of neoadjuvant chemoimmunotherapy before surgery. Adjuvant chemotherapy was also administered for 2-3 cycles after surgery. In addition, MRD was detected within 30 days before surgery, 1 week after surgery, 1 month ±7days after surgery, 6 months after surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab plus chemotherapy | Drug | Sintilimab: 200 mg via intravenous infusion on Day 1 of each 21-day cycle for 2-3 cycles in the neoadjuvant therapy and the maintenance therapy. Chemotherapy drugs: carboplatin/cisplatin+Pemetrexed/gemcitabine/albuminpaclitaxel. Carboplatin: AUC 5 via intravenous infusion, administered in 3-week (21 days) cycles for 2-3 cycles before and after surgery respectly. Cisplatin: 75 mg/m2 via intravenous infusion, administered in 3-week (21 days) cycles for 2-3 cycles before and after surgery respectly. Pemetrexed: 500mg/m2 via intravenous infusion, administered in 3-week (21 days) cycles for 2-3 cycles before and after surgery respectly. Gemcitabine:1.0g/m2 via intravenous infusion in day1 and day8, administered in 3-week (21 days) cycles for 2-3 cycles before and after surgery respectly. Albuminpaclitaxel: 260 mg/m2 via intravenous infusion, administered in 3-week (21 days) cycles for 2-3 cycles before and after surgery respectly. |
| Measure | Description | Time Frame |
|---|---|---|
| Event free survival(EFS) | Defined as the time from randomization to the occurrence of any event, including disease progression, discontinuation of treatment for any reason, or death | Six months after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Defined as the time from the first dose of study drug to death due to any cause. | Six months after the surgery |
| Objective Response Rate (ORR) | Defined as the percentage of participants having complete response or partial response to protocol treatment. Objective response will be measured by RECIST 1.1. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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Patient initially diagnosed with resectable stage III-IIIA/IIIB non-small cell lung cancer t the First Hospital of Jilin University.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kewei Ma | Contact | 0431-88782179 | makw@jlu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital Of Jilin University | Recruiting | Changchun | Jilin | 130000 | China |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Six months after the surgery |
| Disease-Control Rate (DCR) | Defined as the proportion of patients with complete response, partial response, and stable disease. | Six months after the surgery |
| Pathological complete response rate(PCR) | Defined as the absence of residual tumor cells (RVT) in the tumor bed in the pathological response assessment of postoperative specimens after neoadjuvant therapy (the criterion of most studies also includes the absence of tumor residue in the lymph nodes). | At the end of 2-3 cycles of neoadjuvant therapy (each cycle is 21 days) |
| Major pathological response rate (MPR) | Defined as the proportion of residual surviving tumor cells in the tumor bed in the postoperative specimen is less than or equal to 10%. | At the end of 2-3 cycles of neoadjuvant therapy (each cycle is 21 days) |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |