Lung Cancer
Conditions
Interventions
Group A: pCR after neoadjuvant therapy:None
Group B: No pCR was achieved after neoadjuvant therapy:None
Sponsors
General Hospital of Ningxia Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Age >=18 and = 1.5 × 10?/L Platelets >=75 × 10?/L Hemoglobin >= 90 g/L (2) Coagulation function: International normalized ratio (INR) = 2+, a 24-hour urine protein test may be performed; patients may be included if 24-hour urine protein < 1.0 g. Additional laboratory criteria: Total bilirubin <= 1.5 × ULN(Patients with Gilbert’s syndrome: total bilirubin must be < 3 × ULN) AST and ALT <= 2.5 × ULN(<= 5 × ULN for patients with liver metastases) 6.Voluntarily provides written informed consent before participation in the study.
Exclusion criteria
Exclusion criteria: 1.History of pneumonia, upper gastrointestinal bleeding, esophageal fistula, esophageal perforation, or thoracic abscess within 6 months prior to the start of study treatment. 2.Active autoimmune disease or a history of autoimmune disease with a risk of recurrence (e.g., interstitial pneumonitis, uveitis, colitis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism [patients on stable hormone replacement may be included]). The following conditions are not exclusionary and may be further evaluated: Hypothyroidism managed solely with hormone replacement Well-controlled type I diabetes mellitus Well-controlled celiac disease Localized skin diseases not requiring systemic therapy (e.g., vitiligo, psoriasis, alopecia) Any other autoimmune condition unlikely to recur without external triggers 3.Any active malignancy within = 500 IU/mL); active hepatitis C (HCV antibody positive with HCV RNA above the lower limit of detection); or HBV/HCV coinfection. 5.Prior anti-angiogenic therapy or radiotherapy for the current lung cancer. 6.Receipt of a live vaccine within =140 mmHg or diastolic >=90 mmHg). 19.Newly diagnosed angina within 3 months prior to screening; myocardial infarction within 6 months prior to screening; clinically significant arrhythmias (including QTcF >=450 ms for men, >=470 ms for women) requiring long-term antiarrhythmic therapy; NYHA class >= II heart failure; or uncontrolled heart failure. 20.Clinically significant hemoptysis within 3 months prior to study entry (>50 mL/day), or active bleeding, or bleeding tendency (e.g., gastrointestinal bleeding, gastric ulcer bleeding, hematemesis, hemorrhagic ulcer, positive fecal occult blood above baseline, vasculitis).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease?free survival (DFS) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS); | — |
Countries
China
Contacts
Public ContactLv Ye
General Hospital of Ningxia Medical University
Outcome results
None listed