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Immune Checkpoint Inhibitor Combined With Pemetrexed Intrathecal Injection for Leptomeningeal Metastasis From Solid Tumors

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 32 days later Jul 31, 2026 → Sep 2026
See other at-risk trials from Guangzhou Medical University

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fields
  2. Primary and study completion pushed from Jul 31, 2026 to Sep 2026 Show 4 more changesShow less
    • Study sites: 4 to 5
    • Eligibility criteria expanded, about 7 words
    • Publications: details revised at 2 of 2 entries
    • Collaborators expanded, about 4 words
  3. Primary completion date: Jan 30, 2026 to Jul 31, 2026
    • Study sites: 1 to 4
    • Study completion date: Jul 30, 2026 to Jul 31, 2026
    v6
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 34 to confirmed 45
    • Study completion date: Apr 30, 2026 to Jul 30, 2026
    • Site details revised
    v5
  5. Primary endpoints: 3 to 2
    • Secondary endpoints shortened, about 6 words
    • Study description expanded, about 1 word
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Study Identification, Study Status, Oversightv3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Apr 20, 2026 to Jan 30, 2026
    • Study completion date: Jun 20, 2026 to Apr 30, 2026
    • Start date changed from estimate of Jun 20, 2024 to Jun 30, 2024
    • Study site revised
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06462222
Lead Sponsor Guangzhou Medical University
Collaborators: Jinshan Hospital Fudan University
Conditions
(from sponsor)		 Leptomeningeal Metastasis
Related terms Meningeal Carcinomatosis
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov