Safety and Efficacy of Whole Brain LDRT+ICI+Intrathecal Chemotherapy in Refractory Meningeal Metastasis of Lung Cancer

Launched by SICHUAN UNIVERSITY · May 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with lung cancer that has spread to the membranes surrounding the brain, a condition known as leptomeningeal metastasis. The researchers want to see if combining low-dose radiation therapy to the whole brain, immunotherapy (a type of treatment that helps the immune system fight cancer), and chemotherapy delivered directly into the spinal fluid is safe and effective. This is a Phase 1 trial, meaning they are primarily focusing on understanding the safety of this treatment in people who have not responded to standard therapies.

To be eligible for this trial, participants must be between 18 and 75 years old, have a confirmed diagnosis of leptomeningeal metastasis, and have a history of lung cancer that hasn't improved with regular treatments. Participants should also be able to provide samples for testing and have certain health conditions stable, such as normal organ function. If someone joins the study, they can expect to receive these treatments under careful supervision and monitoring by the medical team. It’s important to know that there are specific health criteria, and potential participants should discuss their options with a healthcare provider to see if they qualify.

Gender

ALL

Eligibility 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:
• • ① Hemoglobin ≥80 g/L, neutrophils ≥1.5×10\^9/L and platelets ≥70×10\^9/L;
• • ② 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:
• • 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;
• • 9. Pregnant and lactating women, subjects with reproductive capacity are unwilling to take effective contraceptive measures.