lung cancer
Conditions
Interventions
1:WB-LDRT 4Gy/2f, D1,2
+ICI: PD-1 inhibitor+Pem, iv
IP: Pem 30mg
2:WB-LDRT 8Gy/4f, performed on days 1 and 2 of Cycles 1 and 2, respectively
+ICI: PD-1 inhibitor+Pem, iv
IP: Pem 30mg
3:WB-LDRT 16Gy/8f, performed on days 1 and 2 of cycles 1, 2, 3 and 4 respectively
+ICI: PD-1 inhibitor+Pem, iv
IP: Pem 30mg
Sponsors
Thoracic Oncology Ward, West China Hospital, Sichuan University, Chengdu, Sichuan, China
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. = 18 years old and = 75 years old; 2. Patients with a definite diagnosis of leptomeningeal metastasis by cerebrospinal fluid cytology, or patients with clinical diagnosis combined with tumor history, neuroimaging, clinical manifestations, cerebrospinal fluid examination, etc.; 3. Patients with a clear history of lung carcinoma, including histopathological diagnosis or a combination of cytopathology and imaging, and failure of standard treatment; 4. Efficacy of extracranial lesions SD; 5. Patients with no contraindications to craniocranial radiotherapy were judged by radiotherapy doctors. Subjects who agree to receive immunotherapy, Lumbar puncture, intrathecal chemotherapy, and radiotherapy; 6. Expected survival =3 months, PS score =3; 7. Agree to provide cerebrospinal fluid, blood and tissue samples for biomarker testing; 8. The main organs function normally, no serious blood, heart, lung, liver, kidney, bone marrow and other functional abnormalities and immune deficiency diseases; 9. One week before enrollment, bone marrow and liver and kidney function met the following criteria: ? Hemoglobin =80 g/L, neutrophils =1.5×109/L and platelets =70×109/L; ? Renal function: Cr=ULN (upper limit of normal) × 1.5, endogenous creatinine clearance (Ccr)=55 ml/min; Liver function: total bilirubin =ULN × 1.5; ALT, AST=ULN × 2.5; (In case of liver metastasis, total bilirubin should not be higher than 3 times the upper normal limit, and transaminase should not be higher than 5 times the upper normal limit); 10. The fertile women agreed to use contraception during the study period and for 6 months after the study ended; Patients who tested negative for a serum or urine pregnancy test within 7 days prior to joining the study and were not breastfed; Men who agreed to use contraception during the study period and for 6 months after the study ended
Exclusion criteria
Exclusion criteria: Exclusion Criteria: (1) Active autoimmune disease or history of autoimmune diseases; (2) Congenital or acquired immunodeficiency; (3) Uncontrolled cardiac clinical symptoms or diseases; (4) Severe infection or severe comorbidities, such as bleeding peptic ulcer, ileus, heart failure, renal failure, or poorly controlled diabetes; (5) History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; (6) Other systemic malignancies within the last 5 years; (7) Allergy to any test drug; (8) Uncontrolled epilepsy, neurological failure, or severe treatment-related neurological impairment, uncontrollable psychosis, and other conditions deemed unsuitable for inclusion by the investigator; and (9) pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS-LM;Overall survival; | — |
Countries
China
Contacts
Public ContactLisha Xiang
West China Hospital, Sichuan University
Outcome results
None listed