Non-small cell lung cancer with ypN0 status
Conditions
Interventions
MRD-negative group:Patients undergo dynamic follow-up (without receiving tumor treatment), MRD monitoring, clinical follow-up, and follow-up according to the review cycle.
MRD-positive group:Postoperative immunotherapy with ranibizumab for 1 year.
Sponsors
Second Xiangya Hospital of CSU
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients initially diagnosed with resectable stage cII-IIIA (JACC TNM 8th edition) NSCLC, who is negative for target drug-driven EGFR/ALK genes, and has undergone 3-4 cycles of neoadjuvant chemotherapy combined with immunotherapy (Tislelizumab), followed by radical resection surgery, with pathological evaluation showing negative lymph nodes (ypN0). 2. Patients aged 18 years or older; 3. ECOG performance status score of 0-1; 4. Expected survival of at least 12 weeks; 5. The subject is conscious, capable of understanding the study protocol, and voluntarily participates in this study. They have signed the informed consent form, demonstrate good compliance, and are willing to cooperate with follow-up; 6. At enrollment, the patient can provide biopsy tissue that was pathologically diagnosed as NSCLC at the initial diagnosis, with at least 10 paraffin-embedded slides, and the pathology report indicates that the overall tumor content is not less than 10%, or there is a large panel NGS (Next-Generation Sequencing) test available;
Exclusion criteria
Exclusion criteria: 1. Patients with one or more severe concomitant systemic diseases that, in the opinion of the investigator, would compromise the patient's ability to complete the study; 2. Patients who, in addition to having received 3-4 cycles of neoadjuvant chemotherapy combined with immunotherapy (limited to Tislelizumab), have also received other forms of immunotherapy or radiotherapy (including preoperative and postoperative adjuvant chemotherapy or radiotherapy) or have undergone other systemic anti-tumor treatments; 3. Patients with a history of other malignant tumors within the past 5 years (excluding completely resected basal cell carcinoma, carcinoma in situ of the bladder, and cervical carcinoma in situ); 4. Any unstable systemic diseases (including active infections, uncontrolled hypertension, unstable angina pectoris, congestive heart failure, myocardial infarction within the past year, severe arrhythmias requiring medical treatment, liver, kidney, or metabolic diseases); 5. In the judgment of the investigator, the subject has other factors that may lead to forced discontinuation of the study, such as having other serious diseases (including mental illnesses) requiring concurrent treatment, severely abnormal laboratory test values, familial or social factors that may affect the subject's safety or the collection of trial data;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year DFS rate; | — |
Countries
China
Contacts
Public ContactWenliang Liu
Second Xiangya Hospital of CSU
Outcome results
None listed