NSCLC with malignant pleural effusion
Conditions
Interventions
Tislelizumab intrapleural therapy :Tislelizumab pleural perfusion combined with standard immunotherapy
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1: Age =18 years old 2: Patients confirmed unresectable stage IV NSCLC (v 8th ) 3: At least one measurable lesion, according to RECIST v1.1; 4: Pathology confirmed malignant pleural effusion, and the investigator assessed it as symptomatic pleural effusion 4: No drugs targeting PD-1, PD-L1, BTLA, 4-1BB, CTLA-4 have been used in the past 5: ECOG 0-1 6 Patients who had known EGFR or ALK sensitive mutation should have been resistant to TKIs treated 7: Organ function tolerates further study treatments 8: Expected survival time >3 months; 9: For organ function, subjects must meet the following laboratory criteria: 1) The absolute value of neutrophil (ANC) =1.5x109/L in the past 14 days without the use of granulocyte colony-stimulating factor; 2) Platelets =100×109/L without blood transfusion in the past 14 days; 3) Hemoglobin >9g/dL in the last 14 days without blood transfusion or use of erythropoietin; 4) Total bilirubin =1.5× upper limit of normal (ULN); Or total bilirubin >ULN but direct bilirubin = ULN; 5) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =2.5×ULN (ALT or AST =5×ULN in patients with liver metastasis); 6) Serum creatinine =1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) =50 ml/min; 7) Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) =1.5 times ULN. If the subject is on anticoagulant therapy, PT should be within the prescribed range of anticoagulants. 10:(11) For female subjects of reproductive age, a urine or serum pregnancy test should be given and the result is negative within 3 days prior to receiving the first study drug administration (day 1 of cycle 1). If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is requested. Women of non-reproductive age were defined as at least one year after menopause or having undergone surgical sterilization or hysterectomy; 10:If there is a risk of conception, all subjects (male or female) are required to use a contraceptive with an annual failure rate of less than 1% for the entire duration of treatment up to 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration).
Exclusion criteria
Exclusion criteria: (1) Malignant diseases other than non-small cell lung cancer (excluding radical skin basal cell carcinoma, skin squamous cell carcinoma, and/or radical resection in situ carcinoma) diagnosed within 5 years before the first dose; (2) Receiving any other study drug or participating in an interventional clinical investigation within 28 days before the first dose; Or received treatment with an antineoplastic drug (including Chinese herbal medicine with an anti-tumor indication) within 28 days before the first use of the study drug; (3) Has not fully recovered from any intervention-related toxicity and/or complications before starting treatment (i.e., grade =1 or baseline, excluding fatigue or alopecia); (4) Known symptomatic central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases could participate if their disease was stable (no evidence of progression on imaging for at least 4 weeks before the first dose of trial treatment), they had no evidence of new brain metastases or enlargement of preexisting brain metastases as confirmed on repeat imaging, and they did not require steroids for at least 14 days before the first dose of trial treatment. This exception does not include carcinomatous meningitis, which should be excluded regardless of clinical stability; (5) Pregnant or lactating; (6) Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation (7) Patients with a known history of human immunodeficiency virus (HIV) infection or confirmed immunotesting positive, active or clinically poorly controlled severe infection; (8) Ascites or pericardial effusion with obvious clinical symptoms requiring drainage; (9) Acute or chronic active hepatitis B or hepatitis C infection, hepatitis B virus (HBV) DNA>2000IU/ml or 104 copies /ml; Hepatitis C virus (HCV) RNA> 103 copies /ml; Both hepatitis B surface antigen (HbsAg) and anti-HCV antibody were positive. Those who were below the above criteria after nucleotide antiviral therapy could be enrolled. 10) Clinically significant or uncontrolled cardiac conditions, including unstable angina, acute myocardial infarction within 6 months before the first dose, New York Heart Association class III/IV congestive heart failure, and uncontrolled arrhythmia (pacemaker allowed or in subjects with atrial fibrillation and well controlled rate); (11) Presence of ECG changes or medical history considered by the investigator to be clinically significant; Subjects with a QTcF interval of more than 480 msec were screened, and a JTc interval could be used instead of a QTc interval for intraventrial-conduction block (a QRS interval of >120 msec), with approval from the sponsor (if a JTc interval was used instead of a QTc interval, the JTc interval had to be =340 msec). (12) Uncontrolled hypertension, systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg with the best medical treatment, history of hypertensive crisis or hypertensive encephalopathy; (13) Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh class B or worse cirrhosis. (14) Had undergone a major surgical procedure (craniotomy, thoracotomy, or laparotomy) within 4 weeks before the first dose of study treatment or was anticipated to require major surgery during the study treatment; (15) Pregnant or lactating women, or those expected to become pregnant or give birth during the study period from the screening visit to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pleural effusion control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;Disease control rate, DCR;Duration of response,DOR;Progression free survival;adverse event; | — |
Countries
China
Contacts
Public ContactCheng CHEN
The First Affiliated Hospital of Soochow University
Outcome results
None listed