Malignant pleural effusion
Conditions
Interventions
Recombinant human adenovirus type 5 injection:Subjects were administered by Ankerex on Day 1, Day 3 and Day 5 at a dose of 3 sticks/time (approximately 1.5×10^12 VP/time). The investigator can assess
Sponsors
Nanjing Tianyinshan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate, sign the informed consent form, and have good compliance, and be able to cooperate with diagnosis and treatment and follow-up; 2. Age>=18 years old, male or female; 3. Subjects with malignant tumors confirmed by histopathological and/or cytological examination, pleural effusion must be confirmed by pathology (malignant cells are found in cell precipitation, or pathological changes of malignant tumors are observed in pleural biopsy tissues) or clinically diagnosed as malignant pleural effusion; 4. Have a moderate amount or above of pleural effusion, and clinical judgment requires local treatment for pleural effusion; Definition of moderate effusion and above: maximum depth of pleural effusion >=4 cm on sitting B-ultrasound, or >=500 mL as assessed by CT pleural effusion; 5. Physical condition: ECOG PS=3 months; 7. The function of the main organs is basically normal, and the laboratory examination meets the following criteria: a) Absolute hematological neutrophil count >=1.5×10^9/L, platelet >=75×109/L, hemoglobin >=80 g/L. b) Renal serum creatinine 50 mL/min (calculated using the Cockroft Gault formula [see Appendix 2]). c) Liver serum total bilirubin <2×ULN; Subjects without liver metastases: AST and ALT<2.5×ULN; Liver metastases Subjects: AST and ALT<5×ULN; d) International normalized ratio (INR) or prothrombin time (PT) of coagulation function <1.5×ULN, if the subject is receiving anticoagulation therapy, the coagulation index needs to be within the intended range of anticoagulant drugs, and the investigator needs to evaluate that it will not increase the risk of participating in this study to undergo thoracentesis catheterization; 8. Female subjects of childbearing potential with a negative serum pregnancy test within 7 days prior to the start of the study; Female/male subjects of childbearing potential must be willing to practice a reliable method of contraception throughout the study period (screening period to 90 days after the last dose of study drug), including but not limited to: abstinence, male partner has undergone vasectomy, female sterilization surgery, effective intrauterine device, and effective contraceptives.
Exclusion criteria
Exclusion criteria: 1.Have participated in other clinical studies and received study treatment within 4 weeks prior to or during the first administration of medication; 2.If the subject has received systemic chemotherapy or thoracic perfusion drug treatment within 14 days before the first administration, and has not experienced severe adverse events (grade 3/4) during recent anti-tumor treatment, or has recovered to = grade 2 during the screening period, and the subject's general condition is stable according to the researcher's evaluation, the shortest washout period can be 7 days. Existing systemic treatments (such as regularly used targeted drugs, endocrine therapy drugs, etc.) do not require elution; 3.AE with a grade greater than 1 that has not recovered from previous treatment, unless some AE with a grade 2 that has not recovered has been judged by the researcher to have stable symptoms and does not affect the safety of participants in this study, such as hair loss; 4.Patients with contraindications for thoracentesis or those with encapsulated fluid on the planned treatment side; 5.Within 6 months prior to the first use of medication, there have been incidents of arterial/venous thrombosis, such as cerebrovascular accidents (including ischemic stroke and cerebral hemorrhage), deep vein thrombosis, and pulmonary embolism; 6.Has a serious history of cardiovascular and cerebrovascular diseases, including but not limited to: having experienced myocardial infarction within 6 months, or currently having unstable angina, arrhythmia, etc; Congestive heart failure with NYHA functional class >= II; 7.Subjects with uncontrolled primary brain tumors or central nervous system metastases who exhibit significant intracranial hypertension or neurological symptoms, or have other evidence of uncontrolled central nervous system metastases, are deemed unsuitable for inclusion by the researchers. The following situations are eligible to participate in this study: subjects who have completed radiotherapy or surgery for central nervous system metastasis more than 4 weeks before enrollment, and whose nervous system has been stable for >= 4 weeks; 8.Suffering from uncontrollable neurological and psychiatric disorders, mental disorders, or substance abuse that may affect research compliance; 9.There are active infections (viruses, fungi, or bacteria) that require systemic treatment, except for those who are positive for hepatitis B and/or C; 10.Known history of human immunodeficiency virus (HIV) infection; 11.Individuals with a history of allergies to similar biological agents, such as those allergic to adenovirus vector vaccines; 12.Pregnant or lactating female subjects; 13.The subject has known activity or suspected autoimmune disease. Allow subjects who are in a stable state and do not require systemic immunosuppressive therapy to be enrolled; 14.There are medical histories or diseases, treatments or laboratory abnormalities that may interfere with the research results, hinder the full participation of the subjects in the study, or the researchers believe that participating in the study is not in the best interests of the subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of puncture drainage within the first 60 days;Time to Repeat Puncture (TTRP);3-month overall survival rate;Objective relief rate of pleural effusion; | — |
Countries
China
Contacts
Public ContactYingxia Chen
Nanjing Tianyinshan Hospital
Outcome results
None listed