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This is the first prospective clinical study to evaluate the efficacy and safety of induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy in patients with unresectable locally advanced non-small cell lung cancer (NSCLC). Based on this prospective study, tumor tissue, blood, urine, and stool samples from participants will be collected and analyzed to identify predictive markers of treatment response.
All patients had a pathologically confirmed locally advanced NSCLC according to the 8th AJCC staging system would receive platinum-based doublet chemotherapy and immunotherapy, followed by carbon iron radiotherapy and immunotherapy. The concrete immune checkpoint inhibitor includes durvalumab, sugemalimab, atezolizumab, benmelstobart, pembrolizumab, camrelizumab, toripalimab, tislelizumab, sintilimab, nivolumab, serplulimab, or penpulimab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction chemoimmunotherapy followed by carbon ion radiotherapy and consolidation immunotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbon ion radiotherapy | Radiation | Patients will receive platinum-based doublet chemotherapy and immunotherapy, followed by carbon iron radiotherapy and immunotherapy. The concrete immune checkpoint inhibitor includes durvalumab, sugemalimab, atezolizumab, benmelstobart, pembrolizumab, camrelizumab, toripalimab, tislelizumab, sintilimab, nivolumab, serplulimab, or penpulimab. |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year PFS | Time between enrollment and recurrence of disease or death | 12 months |
| Incidence of Grade ≥3 Treatment-Related Adverse Events | Safety | Occurrence or end of follow-up(3 years after enrollment), which comes first |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Time between enrollment and death | Occurrence or end of follow-up(3 years after enrollment), which comes first |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker Analysis | Including ctDNA levels and their correlation with treatment response; additional biomarkers include PD-L1 expression, TMB, RNA expression profiles, immune cell subtypes, cytokines, metabolites, tumor and gut microbiota | 36 months |
Inclusion Criteria:
Exclusion Criteria:
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Patients with unresectable locally advanced non-small cell lung cancer (according to the 8th edition of the AJCC staging system).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongling JI, MD | Contact | 0086-571-88122088 | drjyl@msn.com | |
| Min Fang | Contact | 0086-571-88122088 | 541387924@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Yongling JI, MD | Zhejiang Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D063193 | Heavy Ion Radiotherapy |
| D004358 | Drug Therapy |
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
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tumor tissue, blood, urine, and stool samples
|
| Chemotherapy | Drug | platinum-based doublet chemotherapy |
|
| Immunotherapy | Drug | The concrete immune checkpoint inhibitor includes durvalumab, sugemalimab, atezolizumab, benmelstobart, pembrolizumab, camrelizumab, toripalimab, tislelizumab, sintilimab, nivolumab, serplulimab, or penpulimab. |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |