Actively Recruiting
Safety and Efficacy of Whole Brain LDRT+ICI+Intrathecal Chemotherapy in Refractory Meningeal Metastasis of Lung Cancer
Led by Sichuan University · Updated on 2026-05-08
10
Participants Needed
1
Research Sites
140 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase I study aims to investigate the safety and efficacy of whole brain low dose radiotherapy (WB-LDRT) combined with ICI and intrathecal chemotherapy for treatment of refractory meningeal metastasis of lung cancer.
CONDITIONS
Official Title
Safety and Efficacy of Whole Brain LDRT+ICI+Intrathecal Chemotherapy in Refractory Meningeal Metastasis of Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Definite diagnosis of leptomeningeal metastasis by cerebrospinal fluid cytology or clinical diagnosis combined with tumor history, neuroimaging, clinical signs, and cerebrospinal fluid tests
- Clear history of lung cancer confirmed by histopathology or cytopathology and imaging, with failure of standard treatment
- Stable extracranial lesions (SD)
- No contraindications to cranial radiotherapy as judged by radiation oncologists
- Willingness to receive immunotherapy, lumbar puncture, intrathecal chemotherapy, and radiotherapy
- Expected survival of at least 3 months and performance status score of 3 or less
- Agreement to provide cerebrospinal fluid, blood, and tissue samples for biomarker testing
- Normal main organ function without serious abnormalities in blood, heart, lung, liver, kidney, bone marrow, or immune deficiency diseases
- Bone marrow, liver, and kidney functions meeting specific laboratory criteria within one week before enrollment
- Women of childbearing potential agree to use contraception during the study and for 6 months after; negative pregnancy test within 7 days before enrollment and not breastfeeding; men agree to use contraception during the study and for 6 months after
You will not qualify if you...
- Active or history of autoimmune diseases
- Congenital or acquired immunodeficiency
- Uncontrolled heart symptoms or diseases
- Severe infections or serious comorbidities such as bleeding ulcers, ileus, heart failure, renal failure, or poorly controlled diabetes
- History of allogeneic organ or hematopoietic stem cell transplantation
- Other systemic cancers within the last 5 years
- Allergy to any study drug
- Uncontrolled epilepsy, neurological failure, severe neurological impairment from treatment, uncontrollable psychosis, or other conditions making participation unsuitable
- Pregnant or breastfeeding women, or those with reproductive ability unwilling to use effective contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
Y
You Lu, MD
CONTACT
L
Lisha Xiang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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