Malignant pleural effusion
Conditions
Interventions
Experimental group:Photodynamic therapy (PDT) combined with standard platinum-based doublet chemotherapy and PD-1 antibody
Control group:Standard platinum-based doublet chemotherapy combined with PD-1 antibody
Sponsors
The Affiliated Hospital of Southwest Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Baseline Disease (1) Patients with newly diagnosed non-small cell lung cancer (NSCLC) complicated by malignant pleural effusion, confirmed by pathology.(2) Pleural effusion volume >= 500 ml (moderate or above), confirmed by ultrasound or CT as free fluid (non-encapsulated). (2) Diagnostic criteria for malignant pleural effusion:Pleural effusion confirmed as malignant by pathological examination, or meeting the following clinical criteria:1) Lung cancer already diagnosed, with no other explanation for the source of pleural effusion;2) Lung cancer with pleural effusion, and imaging findings (CT, PET-CT, MRI, or ultrasound) showing pleural nodules, masses, or irregular thickening consistent with pleural metastasis. 2.Clinical Characteristics(1) Age 18–75 years, ECOG performance status 0–2, expected survival >= 3 months.(2) No prior systemic therapy for the current lung cancer (including chemotherapy, immunotherapy, targeted therapy, or PDT) and no prior local therapy (such as pleurodesis or chest tube drainage). 3. Laboratory Parameters(1) Hematological function: Neutrophils >= 1.5 × 10^9/L, platelets >= 75 × 10^9/L, hemoglobin >= 90 g/L.(2) Hepatic and renal function: ALT/AST = 50 ml/min. 4.Group Matching CriteriaPD-L1 expression level testing (1% <= TPS < 50%), and exclusion of patients with confirmed driver gene mutations such as EGFR, ALK, or ROS1. 5.Informed ConsentPatients and their families sign the informed consent form, voluntarily participate in the study, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to photosensitizers or related drugs; 2. Severe pulmonary dysfunction with dyspnea and inability to lie on one side; 3. Extensive pleural adhesions; 4. Comorbid severe diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, and uncontrolled hypertension; 5. Cachectic state; 6. Active bleeding or hemorrhagic diathesis (abnormal coagulation mechanism or prothrombin time below 40%); 7. Pregnant or lactating women; 8. Expected survival time less than 3 months; 9. Paraneoplastic or tumor-related pleural effusions without tumor cells in the pleural fluid, caused indirectly by non-tumor factors such as mediastinal tumor infiltration, bronchial obstruction, radiotherapy, pulmonary infarction, and superior vena cava syndrome; 10. Previous local pleural therapy (such as pleurodesis); 11. Psychiatric illness or poor compliance, preventing completion of the treatment plan and follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR of PDT combined with systemic therapy in lung cancer patients with malignant pleural effusion; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of grade 3 or higher adverse events, quality of life and symptom improvement in patients with lung cancer - associated malignant pleural effusion treated with photodynamic therapy combined with systemic therapy;Overall survival of patients with lung cancer and malignant pleural effusion treated with photodynamic therapy combined with systemic therapy;6-month progression-free survival without pleural effusion in patients with lung cancer and malignant pleural effusion treated with photodynamic therapy combined with systemic therapy; | — |
Countries
China
Contacts
Public ContactYuying Li
The Affiliated Hospital of Southwest Medical University
Outcome results
None listed