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Clinical Trials in China / NCT06431685
Recruiting Phase 1

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

NCT06431685 · tracked via the Priya Life Science China tracker
Sponsor
Sichuan University
Phase
Phase 1
Started
2024-04-25
Last updated
2026-05-08

Condition(s) studied

NSCLCLow Dose RadiotherapyPD-1 InhibitorLeptomeningeal Metastasis

Investigational drug(s) / intervention(s)

Whole Brain Low Dose RadiotherapyPemetrexed →Sintilimab →Chemotherapy

Whole Brain Low Dose Radiotherapy: Whole brain LDRT will be administered at 3 cohorts with increasing dose fractions: Group 1: 4 Gy/2f of one cycle; Group 2: 4 Gy/2f of two cycles (Q3w); Group 3: 4 Gy/2f of three cycles (Q3w). WB-LDRT will be administered in a 4 Gy of 2 fractions over two days, starting from Day 1 in the first cycle (a daily dose of 2 Gy, 4 Gy/2f for one cycle, once per three weeks, at minmum in one cycle and maximum in four cycles in total).

Pemetrexed: Pemetrexed, 30 mg, intrathecal injection, once per three weeks, 4 cycles in total

Sintilimab: PD-1 inhibitor (Sintilimab, dose as recommended in the instruction manual), intravenous infusion, once per three weeks, 4 cycles in total

Chemotherapy: Pemetrexed at a dose of 500 mg/m\^2, intravenous infusion, once per three weeks, 4 cycles in total

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
West China Hospital, Sichuan University Chengdu Sichuan Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06431685 on ClinicalTrials.gov ↗ ← All trials in China