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The goal of this clinical trial is to compare the efficacy and safety of neoadjuvant Stereotactic Body Radiotherapy (SBRT) combined with immunochemotherapy versus neoadjuvant immunochemotherapy. The main questions it aims to answer are:
Dose SBRT combined with immunochemotherapy improve event-free survival? Is SBRT combined with immunochemotherapy safe enough?
Participants will:
Receive neoadjuvant SBRT combined with immunochemotherapy or neoadjuvant immunochemotherapy.
Tumor assessment will be performed prior to surgery. Surgery will be performed within 4 to 6 weeks (+ 7 days) after completion of the last cycle of immunochemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neoadjuvant SBRT combined with immunochemotherapy | Experimental | Following admission, intrapulmonary primary stereotactic body radiotherapy (SBRT) was administered at a dosage of 24 Gy across three fractions. Subsequently, within seven days of completing SBRT, two cycles of Tislelizumab in combination with a platinum-based double-agent chemotherapy regimen were initiated. These cycles were repeated every three weeks. Surgical intervention was scheduled to occur 4-6 weeks (±7 days) after the completion of the second chemotherapy cycle |
|
| neoadjuvant immunochemotherapy | Active Comparator | Three cycles of Tislelizumab in conjunction with platinum-based chemotherapy were administered at three-week intervals. Surgical intervention was subsequently scheduled to occur within 4 to 6 weeks (±7 days) following the completion of the third chemotherapy cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic body radiotherapy (SBRT) | Radiation | Radiation source: 6MV photon linear gas pedal is used. Position immobilization: supine position, hands up, vacuum bag or styrofoam immobilization. Radiotherapy plan design: 4DCT positioning, radiotherapy plan design at 20% respiratory time-phase CT, isocentric irradiation, IMRT or VMAT design. Definition of target area: Gross tumor volume (GTV) includes the primary tumor in the lung, excluding lymph nodes. Internal target volume (ITV); Internal target volume (ITV) is formed by the fusion of 10 respiratory phases of GTV; Planning target volume (PTV) is formed by expanding the ITV by 0.5 cm in all directions. |
| Measure | Description | Time Frame |
|---|---|---|
| event-free survival | include 2/3/5 event-free survival time | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| major pathologic response (MPR) rate | 1-year | |
| pathological complete response (PCR) rates | 1-year | |
| R0-resection rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Yang, MD | Contact | 86-020-87343932 | 020-87343932 | yanghong@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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|
| Tislelizumab | Drug | PD-L1 inhibitor |
|
| Chemotherapy | Drug | platinum-based double-agent chemotherapy |
|
| 1-year |
| overall survival | 2/3/5 years overall survival rate | 5 years |
| safety | adverse events rate, postoperative complication rate, mortality rate. | 1-year |
| 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 |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| C000707970 | tislelizumab |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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