Resectable Non-Small Cell Lung Cancer (NSCLC)
Conditions
Interventions
Experimental group:During the mid-term of preoperative neoadjuvant therapy, MWA treatment was performed first, followed by intravenous administration of 240 mg fixed-dose toripalimab Q3W combined with
each cycle is 3 weeks, with administration on day 1 of each cycle.
Sponsors
Beijing Friendship Hospital ,Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign a written informed consent form; 2. Be >=18 years old at the time of signing the informed consent, gender does not matter; 3. Expected survival of >=3 months; 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 5. Histologically confirmed, previously untreated, locally advanced (AJCC 9th edition stage IIA–IIIB) NSCLC without EGFR/ALK mutations; 6. At least one measurable lesion as a target lesion (according to RECIST v1.1 criteria); 7. Screening laboratory test results indicate good organ function; 8. According to the surgeon's assessment, overall lung function can tolerate the planned lung resection surgery or ablation treatment; 9. Male patients with reproductive potential or female patients who may become pregnant must use effective contraception (such as oral contraceptives, intrauterine devices, or barrier methods combined with spermicide) during the trial and continue contraception for 6 months after treatment; 10. Good compliance and cooperation with follow-up.
Exclusion criteria
Exclusion criteria: 1. Presence of distant metastatic disease; 2. Small cell lung cancer (SCLC), large cell neuroendocrine carcinoma (LCNEC), sarcomatoid tumors; 3. Early NSCLC patients who have previously received systemic anticancer therapy, including investigational drugs; 4. Previous treatment with PD-1/PD-L1 agents or other drugs targeting T-cell receptors (e.g., CTLA-4, OX-40, etc.); 5. History of severe allergic reactions to other monoclonal antibodies; 6. Severe allergy history to pemetrexed, cisplatin, carboplatin or their prophylactic medications; 7. Active or suspected active autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc., except for: type I diabetes and hypothyroidism controlled with stable-dose replacement therapy, and skin diseases (e.g., psoriasis, vitiligo) not requiring systemic treatment; 8. History of interstitial lung disease or drug-induced interstitial lung disease/pneumonitis; 9. Use of systemic corticosteroids (prednisone >10 mg/day or equivalent) or other immunosuppressive drugs within 14 days prior to first study drug administration; 10. History of immunodeficiency, including other acquired or congenital immunodeficiency diseases, history of organ transplantation, or receipt of allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 11. Received live vaccines within 4 weeks prior to first study drug administration; 12. Severe cardiovascular or cerebrovascular diseases; 13. Uncontrolled or severe underlying diseases, including but not limited to active infections requiring systemic antibiotic treatment; 14. Positive HIV antibody test, active hepatitis B or C; 15. Known active pulmonary tuberculosis (TB). Patients suspected of active TB should have chest X-ray, sputum examination, and clinical signs and symptoms assessed to rule out TB. 16. History within the past 2 years of other active malignancies besides the study disease, except for malignancies expected to be cured after treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or breast ductal carcinoma in situ treated with radical surgery); 17. History of substance abuse that cannot be discontinued or history of psychiatric disorders; 18. Pregnant or lactating women; 19. Other severe, acute, or chronic medical or psychiatric conditions or laboratory abnormalities that, in the investigator's judgment, may increase risk participation in the study or interfere with interpretation of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR; | — |
Countries
China
Contacts
Public ContactHu Mu
Beijing Friendship Hospital ,Capital Medical University
Outcome results
None listed