Lung cancer
Conditions
Interventions
Dose Escalation Phase:Tislelizumab intrapleural injection (dose escalation: 40mg, 60mg, 80mg, reference to bevacizumab intrapleural injection 5mg/kg, one-third of systemic dose)
Dose Expansion Phase:Tislelizumab intrapleural injection (optimal dose determined based on dose escalation results)
Sponsors
The Second Affiliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with advanced non-small cell lung cancer (via histological or pathological examination);2. Presence of significant unilateral or bilateral pleural effusion shown by chest X-ray, ultrasound, or CT scan;3. Detection of malignant tumor cells in the pleural effusion;4. Failure of first-line intrapleural drug therapy, such as cisplatin or bevacizumab;5. Karnofsky Performance Status (KPS) > 60, age between 18 and 75 years (inclusive) at enrollment, and expected survival > 3 months;6. No major organ system dysfunction, with blood cell counts and cardiac, liver, and kidney function test results within normal ranges.
Exclusion criteria
Exclusion criteria: 1. History of allergy to biologic agents; 2. History of severe adverse reactions to PD-1 antibodies; 3. No detectable lesions; 4. Uncontrolled central nervous system metastases; 5. Severe organ dysfunction, such as congestive heart failure, malignant arrhythmias, coronary artery spasm requiring long-term medication, valvular heart disease, myocardial infarction, and refractory hypertension; 6. Breastfeeding or pregnant women; 7. Infected wounds; 8. History of refractory mental illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pleural effusion control rate;Tumor burden change;Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom improvement (dyspnea, chest pain, etc.);Tumor marker levels;Immune cell subset proportions and activity (e.g., CD8+ T cells including CD69+, IFN-?+, granzyme B+);Cytokine levels (e.g., TNF-a, IL-1ß, CCL20);Gene expression profiles of tumor and immune cells; | — |
Countries
China
Contacts
Public ContactFan Chengjuan
The Second Affiliated Hospital of Harbin Medical University
Outcome results
None listed