Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will be conducted at Fujian Provincial Cancer Hospital. Its main goals are to evaluate the progression-free survival (PFS) and safety of postoperative immunotherapy combined with radiotherapy in patients with high-risk stage Ⅲ N2 non-small cell lung cancer after surgery. It will also assess the overall survival (OS) of this treatment as a secondary goal.
This study has been approved by the Medical Ethics Committee of Fujian Provincial Cancer Hospital, and the rights and safety of all participants will be fully protected during the trial.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tislelizumab + Chemotherapy Arm | Experimental | This arm includes postoperative non-small cell lung cancer patients receiving Tislelizumab (standard intravenous dose) combined with platinum-based chemotherapy (adjuvant regimen), without additional radiotherapy. |
|
| Tislelizumab + Chemotherapy + Radiotherapy Arm | Experimental | This arm includes postoperative non-small cell lung cancer patients receiving Tislelizumab + platinum-based chemotherapy (same as Group A), plus focal radiotherapy (50Gy to the lesion area). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab + platinum-based chemotherapy | Drug | Tislelizumab (200mg IV every 3 weeks) combined with platinum-based chemotherapy (postoperative adjuvant regimen). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | The time from randomization to the first occurrence of disease progression (per RECIST 1.1 criteria) or death from any cause; assessed every 3 months. | Every 3 months, up to 24 months after randomization |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiancheng Li, MD | Contact | +86-13906900190 | jianchengli6@126.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Provincial Cancer Hospital | Recruiting | Fuzhou | Fujian | 350014 | China |
At the current stage, the IPD sharing plan has not yet been finalized. Following study completion, we will conduct a comprehensive evaluation of data sharing feasibility-including considerations related to participant privacy protection, data standardization, and regulatory compliance-before determining a specific sharing framework based on study progress and relevant requirements.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tislelizumab + platinum-based chemotherapy + focal radiotherapy | Drug | Tislelizumab + platinum-based chemotherapy (same as above) plus focal radiotherapy (50Gy total dose to the lesion). |
|
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D017671 | Platinum Compounds |
| ID | Term |
|---|---|
| D007287 | Inorganic Chemicals |
Not provided
Not provided