Stage III non-small cell lung cancer
Conditions
Interventions
intervention group:neoadjuvant hypofractionated radiotherapy combined with Camrelizumab + surgery
control group:neoadjuvant chemotherapy combined with Camrelizumab + surgery
Sponsors
Department of Oncology, Affiliated Hospital of Southwest Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed patients with stage III NSCLC who have not previously received anti-tumor therapy and have clear stages, such as chest enhanced CT, liver and adrenal CT, cranial magnetic resonance imaging, PET-CT/ whole-body bone imaging; Or patients who had previously received radical treatment but experienced disease recurrence or progression 6 months after completion of treatment; 2. Aged 18-75 years, able to express informed consent and sign informed consent, and able to comply with the study protocol and follow-up procedures; 3. Subjects with non-small cell lung cancer whom the attending thoracic surgeon considers acceptable for lobectomy; 4. Life expectancy is greater than 6 months; 5. ECOG score 0-2 in the Eastern Oncology Cooperative; 6. Willing to provide tissue from tumor lesions; 7. Adequate lung function is required: 1 second forced respiratory volume (FEV1) >= 1.2 L/s or >= 50% expected value, postoperative expected value (FEV1) >= 30%; 8. No previous history of other lung malignancies, and no chemotherapy or radiotherapy for lung tumors; 9. Patients who received radiotherapy, chemotherapy, and hormone therapy more than 4 weeks ago, and all adverse events caused by previous treatment have recovered to = 9.0 g/dL (which can be maintained or exceeded by transfusion); Erythrocyte count >= 2.0 x 10^9/L; Neutrophil absolute count (ANC) >= 1.0 x 10^9/L; Platelet count >= 90 x 10^9/L; Total bilirubin = 60mL/min. International standardized ratio of prothrombin time (INR) <= 1.5 and partial thrombin time (APTT) <= 1.5 times the upper limit of normal in patients who did not receive anticoagulant therapy. Patients receiving full or parenteral anticoagulant therapy may be enrolled as long as the dose of anticoagulant has been stable for at least 2 weeks prior to entering the clinical study and their coagulation function is within the limits of local treatment; Laboratory values for other screening tests must meet relevant standards; 11. Women of childbearing age should test urine and serum HCG within 7 days before treatment, and the results should be negative; Age-appropriate men and women must use a reliable method of contraception before entering the trial and during the study until 30 days after stopping the drug. Reliable contraceptive methods will be determined by the principal investigator or designee.
Exclusion criteria
Exclusion criteria: 1. Patients with known ALK translocation, EGFR or BRAF mutation, and ROS1 gene rearrangement; 2. Any unstable systemic disease, including active infection, out of control of high blood pressure, unstable angina, angina onset within the past 3 months, congestive heart failure (New York heart association class II or higher), all infarction (group into the first 6 months), need drug therapy of severe arrhythmia, liver, kidney or metabolic disease; 3. Patients with uncontrolled neuropathy (grade 2 or above) or psychosis; Have active, known or suspected autoimmune diseases; Subjects with vitiligo, type I diabetes, and residual hypothyroidism due to autoimmune thyroiditis; 4. Failure or progression after prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies (or any other antibody acting on T cell co-stimulation or checkpoint pathways); 5. Chest X-ray, sputum examination, and active tuberculosis considered by nucleic acid-PCR; A history of active tuberculosis treatment within 1 year; Patients with more than 1 year of active tuberculosis history had more than 1 year of focal control and positive curative effect of anti-tuberculosis treatment; 6. A known history of HIV positive testing or a known acquired immune deficiency syndrome (AIDS); In the first line of standard treatment ineffective, adequate communication, clear risk of death, adhere to the use of patients can be enrolled; 7. Complications requiring immunosuppressive drugs or systemic or local use of corticosteroids at immunosuppressive doses; 8. After previous thoracic regional radiotherapy, it was evaluated that large partition radiotherapy could not be performed again; 9. Patients who underwent major surgery or severe trauma within 2 months prior to the first medication; 10. Have received or are expected to receive an organ or bone marrow transplant during the study period; 11. Patients with interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-induced pneumonia, and severely impaired lung function; 12. Allergic to research drugs; 13. Conditions considered unsuitable for inclusion by other researchers after comprehensive assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathological remissions, MPR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Radical resection rate;Objective remission rate, ORR;Overall survival, OS;Treatment-related adverse events;Ease to cut;Progression-free survival, PFS; | — |
Countries
China
Contacts
Public ContactLin Sheng
Department of Oncology, Affiliated Hospital of Southwest Medical University
Outcome results
None listed