Carbon Ion Radiotheray
Conditions
Keywords
non-small cell lung cancer, carbon ion radiotherapy, immunotherapy
Brief summary
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.
Detailed description
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.
Interventions
RADIATIONCarbon ion radiotherapy
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.
DRUGChemotherapy
platinum-based doublet chemotherapy
DRUGImmunotherapy
The concrete immune checkpoint inhibitor includes durvalumab, sugemalimab, atezolizumab, benmelstobart, pembrolizumab, camrelizumab, toripalimab, tislelizumab, sintilimab, nivolumab, serplulimab, or penpulimab.
Sponsors
Ji Yongling
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Unresectable, locally advanced non-small cell lung cancer (according to the 8th edition of the AJCC staging system). * No prior anti-cancer treatment. * No significant internal medical conditions or major organ dysfunction.
Exclusion criteria
* Histological evidence of small cell lung cancer or other primary malignancies * EGFR, ALK, or ROS-1 gene mutations. * Active or prior autoimmune/inflammatory disorders. * Inability to comply with study protocol as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-year PFS | 12 months | Time between enrollment and recurrence of disease or death |
| Incidence of Grade ≥3 Treatment-Related Adverse Events | Occurrence or end of follow-up（3 years after enrollment), which comes first | Safety |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | Occurrence or end of follow-up（3 years after enrollment）, which comes first | Time between enrollment and death |
Other
| Measure | Time frame | Description |
|---|---|---|
| Biomarker Analysis | 36 months | 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 |
Countries
China
Contacts
Primary ContactYongling JI, MD
Backup ContactMin Fang
Outcome results
None listed