Lung cancer
Conditions
Interventions
1:intrapleural administration of sintilimab
Sponsors
General Hospital Of Eastern Theater Command
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years old; 2. Non-small cell lung cancer confirmed by histology or cytology; 3. The first occurrence of pleural effusion and diagnosized with malignant pleural effusion by pathological or cytological method. Pleural effusion is medium or above and needs intervention. 4. ECOG score: 0-2; 5. Estimated survival time = 3 months; 6.The function of the main organs is normal, which meets the following criteria: (1) the criteria for blood testing must be (without transfusions of blood and blood products within 14 days, without the use of G-CSF and other hematopoietic stimulant corrections): a. HB=90 g/L; b. ANC=1.5×109/L; c. PLT=80×10 9/L; (2) the biochemical examination must meet the following standards: a. TBIL 45 ml/min (Cockcroft-Gault formula); 7. Women at childbearing age must have taken reliable contraceptives or have undergone a pregnancy test (serum or urine) within 7 days of entry into the group, and the result is negative, and are willing to use appropriate methods of contraception during the trial and eight weeks after the last administration of the test drug.For males, consent is required to use appropriate methods of contraception or surgical sterilization during the trial and eight weeks after the last administration of the test drug; 8. Subject is voluntary to participate and sign informed consents, and willing to follow-up.
Exclusion criteria
Exclusion criteria: 1. The pleural effusion is asymptomatic and needs no clinical intervention. 2. The patient has contraindications for puncture treatment 3. There are contraindications for immunotherapy (including long-term hormone use, history of radiation pneumonia, etc.) 4. Systemic administration combined with antiangiogenic drugs (including bevacizumab, endu, etc.) during intrathoracic administration 5. Intrapleural administration and systemic administration are targeted drugs (including EGFR-TKIs, ALK / ros1 / met inhibitors, etc.), but patients with pleural effusion for the first time after targeted treatment resistance are allowed to enter the group 6. Active autoimmune diseases (such as vitiligo, psoriasis, hypothyroidism requiring hormone replacement therapy, etc.) 7. Active hepatitis B or hepatitis C patients, HIV patients, active tuberculosis, etc; 8. The active infection needs anti microbial treatment (for example, it needs to be treated with antibacterial, antiviral and antifungal drugs); 9. We have known the history of allogeneic organ transplantation and hematopoietic stem cell transplantation; 10. Patients with interstitial lung disease or previous history of interstitial pneumonia; 11. Those who have a history of abuse of psychotropic substances and are unable to give up or have mental disorders; 12. Having participated in clinical trials of other antineoplastic drugs within 4 weeks before randomization; 13. Having used PD-1 / PD-L1 and other immunotherapy drugs before randomization; 14. Previously or at the same time suffering from other non cured malignant tumors, except for cured skin basal cell carcinoma, cervical carcinoma in situ and superficial bladder cancer; 15. Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraceptive measures; 16. Other conditions that may affect the clinical research and the research results evaluated by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of pleural atresia at Week 5; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of pleural atresia at Week 10;Safety of intrapleural administration of sintilimab;Disease control of extrathoracic lesion; | — |
Countries
China
Contacts
Public ContactYong Song
General Hospital Of Eastern Theater Command
Outcome results
None listed