Malignant Pleural Effusion in Lung Cancer
Conditions
Interventions
Experimental group:Subjects who meet the enrollment criteria receive intrathoracic inffusion of ivocimab after ultrasound-guided thoracic catheterization drainage and complete drainage of pleural effu
Sponsors
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Willing to sign the informed consent form. 2.Age >=18 and =3 months. 5.Patients with pathologically or cytologically confirmed lung cancer. 6.Radiological evidence of moderate-to-large pleural effusion, with cytologically confirmed malignant pleural effusion (MPE) requiring drainage as assessed by the investigator. 7.Adequate organ and bone marrow function, defined as follows: a) Hematologic: Absolute neutrophil count (ANC) >=1.5×10?/L Platelets (PLT) >=100×10?/L Hemoglobin (Hb) >=9 g/dL b) Hepatic: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) =60 mL/min (calculated by Cockcroft-Gault formula; see Appendix) d) Coagulation: International normalized ratio (INR), activated partial thromboplastin time (aPTT), and prothrombin time (PT) =50% as measured by echocardiography (ECHO) or multigated acquisition (MUGA) scan; 8.For Female Patients of Childbearing Potential: Negative serum pregnancy test at screening. Must agree to use highly effective non-hormonal contraception during treatment and for >=3 months after the last dose of the investigational drug. 9.Voluntarily participates in the study and provides written informed consent. Demonstrates good compliance and is willing to adhere to follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Previous intrathoracic injection of bevacizumab or PD-1/PD-L1 inhibitors; 2. Received anti-tumor therapy, including chemotherapy, thoracic radiotherapy, targeted therapy, immunotherapy, and biological therapy, within the previous 2 weeks; 3. Bilateral pleural effusion or simultaneous abdominal effusion, or simultaneous pericardial effusion; 4. Pleural effusion is encapsulated effusion or severe separation; or combined with chylothorax; or concomitant infectious pleural effusion; 5. After chest puncture/drainage in the past, there is still chest tightness and shortness of breath, which are not significantly relieved compared with before, and there are still atelectasis, pulmonary consolidation or other lung lesions that seriously affect respiratory function as determined by the investigator. 6. Known history of allergy to the drugs and components of this regimen, a history of immunodeficiency, or a history of organ transplantation; 7. Serious infection within 4 weeks before the first dose, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; Active infection with systemic anti-infective therapy within 2 weeks prior to the first dose (excluding antiviral therapy for hepatitis B or hepatitis C); 8. History of severe bleeding tendency or coagulation dysfunction; Presence of clinically significant bleeding symptoms within 4 weeks before the first dose, including but not limited to gastrointestinal bleeding, coughing up blood (defined as coughing up or coughing up 1 teaspoon of fresh blood or small blood clots=, or only coughing up blood without sputum, those with blood in sputum are allowed to be enrolled), nasal bleeding (excluding epistaxis bleeding and retracting nasal discharge); Received continuous antiplatelet or anticoagulant therapy within 10 days before the first dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Countries
China
Contacts
Public ContactWang Haiyong
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Outcome results
None listed