Lung cancer
Conditions
Interventions
Experimental Group:The enrolled patients will receive SBRT treatment with the primary lesion, 24Gy/3Fx for three consecutive days. Receive 5mg/Kg of apalolitovolrelli with platinum-based chemotherapy
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate and sign the informed consent form in person; 2. Age: 18-75 years old, gender not limited; 3. Histological or cytological diagnosis of non-small cell lung cancer; 4. Previously untreated individuals at stage c?-III (N2a) who are willing to receive neoadjuvant therapy (staging reference: ACJJ 9th ed, see Attachment 1); 5. Physical condition score ECOG 0-1 (ECOG scoring criteria are attached as Appendix 2); 6. According to the surgeon's assessment, the total lung function is capable of withstanding the proposed lung resection surgery. 7. Before enrollment, tumor tissue specimens can be submitted for pathological diagnosis to confirm the absence of EGFR/ALK sensitive gene mutations and PD-L1 expression detection. 8. No severe abnormalities in hematopoietic function, heart, lung, liver or kidney function, or immune deficiency; Bone marrow function: Absolute neutrophil count (ANC) >=1.5 × 10^9/L, platelet count >=80 × 10^9/L, hemoglobin >=9g/dL; Liver: Serum total bilirubin =60ml/min, urea nitrogen <=200mg/L; 9.Women of childbearing age must undergo a serum pregnancy test within 3 days before the first medication, and the result must be negative
Exclusion criteria
Exclusion criteria: 1. There are locally advanced, unresectable or metastatic diseases; Unresectable conditions are defined by the Multidisciplinary Consensus on the Diagnosis and Treatment of Stage III non-small Cell Lung Cancer (2019 Edition), including partial IIIA, IIIB, and all IIIC stages. They typically include N2 with a short diameter of a single N2 mediastinal lymph node =3cm or multiple lymph nodes fused into clusters (short diameter of lymph nodes on CT >=2cm). T4 and all N3 that invade the esophagus, heart, aorta and pulmonary veins; 2. NSCLC involving the upper sulcus, large cell neuroendocrine carcinoma (LCNEC), and sarcomatoid tumors; 3. Participants with known EGFR-sensitive mutations or ALK translocations (for non-squamous cell carcinoma subjects, the EGFR and ALK mutation status needs to be clarified); 4. Early-stage NSCLC that has previously received systemic anti-cancer treatment, including investigational drug therapy; 5. There is an active infection or a fever of unknown cause > 38.5? within 2 weeks before screening (as determined by the researcher, the subjects with fever caused by tumors can be enrolled); 6. Fertile men or women who are unwilling to take contraceptive measures in the trial, and female patients who are pregnant or breastfeeding; 7. As determined by the researchers, the subjects have other factors that may lead to the forced termination of the study halfway If there are other serious diseases (including mental disorders) that require combined treatment, or if family or social factors may affect the safety of the subjects or the collection of trial data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The main pathological response rate;Disease-free survival period;Safety; | — |
Countries
China
Contacts
Public ContactZhou Guoren;Zhang Zhi;Ye Jinjun
Jiangsu Cancer Hospital
Outcome results
None listed