malignant pleural effusion
Conditions
Interventions
experimental group:photodynamic therapy using intrapleural infusion
control group:no intervention
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Ages 18-75 (including 18-75) years; 2. The subject was confirmed by biopsy to have malignant pleural effusion due to tumor; 3. The subjects presented dyspnea and chest pain due to malignant pleural effusion; 4. Subjects can tolerate medical thoracoscopy and treatment; 5. Subjects can tolerate general anesthesia; 6. If the subject has received chemotherapy or radiation therapy, at least 3 weeks after chemotherapy and/or radiation therapy, and has recovered from all acute toxics associated with such treatment; 7. KPS >= 70 or ECOG 3 months; 9. Volunteer to participate in this study and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Allergic to photosensitizers and other drugs used in this study; 2. Subjects who have failed to respond to other photosensitizers or who have received photosensitizers in the previous 6 months prior to enrollment; 3. Other photosensitive agents (e.g., tetracyclines, sulfonamides, phenothiazines, etc.) used within 4 weeks prior to administration; 4. Participate in any drug clinical trial (as a subject) within 1 month prior to the study; 5. The tumor involves or erodes major blood vessels; 6. There was a bronchopleural fistula; 7. Neutrophile granulocyte 3 times the upper limit of normal reference range 3 times; Or in the case of liver metastasis, ALT or AST > 5 times the upper limit of the normal reference range; Serum bilirubin was 3 times higher than the upper limit of normal reference range; 8. Severe impairment of liver or kidney function; 9. Combined with serious diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, etc; 10. HIV, HCV, syphilitic infection or hepatitis B surface antigen and E antigen were all positive; 11. Accompanied by acute inflammation (especially corrosive inflammation) or clinically significant active infection; 12. Pregnant or lactating women and subjects of childbearing age (including men) who refuse to use appropriate contraception during the study period; 13. The subject is in cachexia state, or the advanced subjects are assessed as unable to tolerate photodynamic therapy; 14. Active bleeding or bleeding constitution (abnormal coagulation mechanism); 15. Subjects with severe physical or mental illness that the investigator believes may affect treatment, evaluation, or poor adherence to the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of autopleurodesis;Pleural effusion volume; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor lesion size and range;survival time;dyspnea;life quality score;KPS/ECOG score;tumor marker; | — |
Countries
China
Contacts
Public ContactSong Xiaolian
Shanghai Tenth People's Hospital
Outcome results
None listed