meningeal metastases in non-small cell lung cancer
Conditions
Interventions
Experimental group:Systemic therapy combined with intrathecal injection of Thiotepa
Control group:Systemic therapy
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1). Age =18 years old, gender unlimited. 2) Patients with non-small cell lung cancer with definite diagnosis and meningeal metastases confirmed by cerebrospinal fluid cytology. 3). Previous standard systemic treatment failed regardless of meningeal metastases occurring at any stage of the disease. 4) The researchers judged that the current physical condition and expected treatment plan were suitable for the treatment plan of this study. 5). ECOG score (see Appendix 2) =4, expected survival > 6 weeks (using 2-cycle assessment to record adverse events). 6). Study participants were able to cooperate with the completion of lumbar puncture and intrathecal injection. 7). Laboratory indicators shall meet the following standards: White blood cell count =3.0×109/L, neutrophil absolute value =1.0×109/L, platelet count =75×109/L, hemoglobin =60g/L; Total bilirubin =1.5×ULN; ALT and AST=5 x ULN; Serum creatinine =1.5×ULN or creatinine clearance =50mL/min. 8). The washout period for those who have previously used any antitumor drug for sheath injection should be 4 weeks. 9). Female patients with reproductive potential (including early menopause, menopause < 2 years and non-surgical sterilization), male patients and male patients' partners must consent to the use of effective contraceptive methods during the study period: surgical sterilization, oral contraceptives, intrauterine devices, sexual restraint or barrier contraception combined with spermicides; Contraception should be continued for 6 months after the last treatment. 10). Sign the informed consent voluntarily and follow the program requirements.
Exclusion criteria
Exclusion criteria: 1). Have not received standard systemic treatment: for example: driver positive lung cancer with meningeal metastases without TKI therapy. 2) The acute stage of high cervical spinal cord mass or spinal cord trauma. Patients with obstructive hydrocephalus. 3). Central nervous system infectious diseases; Or there is local infection, hematoma, open injury, and spinal tuberculosis at the site of lumbar puncture. 4) Serious encephalopathy, grade III-IV leukoencephalopathy confirmed by imaging examination. 5). Patients with unstable systemic diseases, including but not limited to: serious infection, uncontrolled diabetes, unstable angina pectoris, cerebrovascular accident or transient cerebral ischemia, myocardial infarction, congestive heart failure, severe arrhythmia requiring medication, liver, kidney or metabolic diseases. 6). Bad liquid. 7) Allergic to the investigational drug or its active ingredients and excipients. 8) The patient has a medical condition (such as mental illness, etc.) or condition (such as alcohol or drug abuse, etc.) that increases the patient's risk of receiving the trial drug treatment or affects the patient's compliance with the trial requirements, or has the potential to confuse the study results. 9). Other circumstances in which the investigator determines that the patient is not suitable for participation in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety;DCR;OS;PFS; | — |
Countries
China
Contacts
Public ContactXiaohua Liang
Huashan Hospital,Fudan University
Outcome results
None listed