Meningeal metastasis of EGFR-mutated lung adenocarcinoma
Conditions
Interventions
Experimental group:During radiotherapy, 15mg of pemetrexed was injected intrathecally weekly for chemotherapy. Take fumetinib 160mg orally once a day at the same time. After radiotherapy was completed
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Lung adenocarcinoma confirmed by histopathology, and the presence of EGFR mutation is determined by genetic testing; 2. Confirmed meningeal metastasis by cerebrospinal fluid cytology or MRI examination; 3. Age 18-70 years old at the time of signing the informed consent form, male or female; 4. KPS score >=40 points; 5. Expected survival time>=6 months; 6. The function of vital organs meets the following requirements (excluding the use of any blood components and cell growth factors within 14 days): •Normal bone marrow reserve function: white blood cell (WBC) >=3.0×10^9/L, neutrophil count (NEUT) >=1.5×10^9/L, platelet count (PLT) >=80×10^9/L, hemoglobin (Hb) >=90 g/L; •Normal renal function or serum creatinine (SCr) =50 ml/min (Cockcroft-Gault formula); • Normal liver function or total bilirubin (TBIL) <=1.5 times the upper limit of normal (ULN); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels <=2.5 times the upper limit of normal (ULN); 7. Able and willing to comply with the study and follow-up process; 8. Subjects voluntarily join this clinical study, sign the informed consent form, have good compliance, and can cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with any systemic anti-tumor therapy for the target lesion; 2. Previous radiotherapy to the head; 3. Subjects who cannot undergo cerebrospinal fluid examination or cannot undergo cerebrospinal fluid examination. 4. Those who have participated in other clinical trials within 1 month before enrollment; 5. Subjects who have had severe trauma or serious infection within 1 month before enrollment, including but not limited to infectious complications requiring hospitalization, bacteremia, severe pneumonia, etc.; 6. Severe cardiovascular disease: grade II. or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval males >= 450 ms, female >=470 ms); Grade III.~IV. cardiac insufficiency (according to NYHA grading of the New York Heart Society, see Annex 3), or cardiac color ultrasound examination showing left ventricular ejection fraction (LVEF) =500 IU/ml), hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method), or combined with hepatitis B and hepatitis C co-infection; 11. Subjects are allergic to pemetrexed or fumetrexib or cannot be treated with pemetrexed or fumetinib for other reasons; 12. Other conditions that increase the risk associated with participating in the study or the investigational drug, and may cause the subject to be unsuitable for inclusion in the study according to the investigator's judgment; 13. The investigator judges that he is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The clinical remission rate of the subjects; | — |
Secondary
| Measure | Time frame |
|---|---|
| Subject's OS;Subject's PFS;Subject's TTP;Cerebrospinal fluid cytological response rate;Cerebrospinal fluid circulating DNA concentration (ctDNA);Quality of life scores: EORTC-QLQ-C30 and EORTC-BN20; | — |
Countries
China
Contacts
Public ContactJiang Xin
The First Hospital of Jilin University
Outcome results
None listed