Leptomeningeal Metastasis Clinical Trial
Official title:
Immune Checkpoint Inhibitor Combined With Pemetrexed Intrathecal Injection for Leptomeningeal Metastasis From Solid Tumors： a Phase I/II Study
This is an open-label, single-arm, phase I/II trial of immune checkpoint inhibitor combined with pemetrexed intrathecal injection for leptomeningeal metastasis from solid tumors, to evaluate the safety and efficacy.
This is an open-label, single-arm, phase I/II trial of immune checkpoint inhibitor combined with pemetrexed intrathecal injection for leptomeningeal metastasis from solid tumors. The primary endpoint of the phase I study was to determine the recommended phase II dose (PR2D). The primary endpoint of the Phase II study was to assess the safety and clinical response rate of immune checkpoint inhibitor in combination with pemetrexed intrathecally under PR2D, with secondary endpoints of overall survival, and neurological progression-free survival. ;
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