RecruitingPhase 1NCT06431685

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

Phase I Study of Whole Brain Low Dose Radiotherapy Combined With ICI and Intrathecal Chemotherapy for Treatment of Refractory Meningeal Metastasis of Lung Cancer


Sponsor

Sichuan University

Enrollment

10 participants

Start Date

Apr 25, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of low-dose whole-brain radiation, immunotherapy, and chemotherapy injected directly into the spinal fluid for people with lung cancer that has spread to the lining of the brain and spinal cord (a condition called leptomeningeal or meningeal metastasis). **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with lung cancer that has spread to the brain/spinal cord lining, confirmed by spinal fluid testing or a combination of imaging and clinical findings - Standard treatments have stopped working - Your disease outside the brain is stable - Your general health allows you to receive radiation, immunotherapy, and spinal fluid chemotherapy - Your expected survival is at least 3 months and your performance score is acceptable **You may NOT be eligible if...** - You have conditions that prevent spinal taps or brain radiation - You have certain uncontrolled infections or severe organ problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONWhole 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).

DRUGPemetrexed

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

DRUGSintilimab

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

DRUGChemotherapy

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


Locations(1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

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NCT06431685


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