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Trial Title:
Immune Checkpoint Inhibitor Combined With Pemetrexed Intrathecal Injection for Leptomeningeal Metastasis From Solid Tumors
NCT ID:
NCT06462222
Condition:
Leptomeningeal Metastasis
Conditions: Official terms:
Neoplasm Metastasis
Meningeal Carcinomatosis
Pemetrexed
Conditions: Keywords:
Leptomeningeal metastasis
Intrathecal chemotherapy
Immune checkpoint inhibitor
Pemetrexed
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Toripalimab, pemetrexed
Description:
Drug 1: Toripalimab 40 mg; Drug 2: pemetrexed 15mg. intrathecal injection therapy
Arm group label:
Group
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Histologically or cytologically confirmed diagnosis of solid tumors; Cerebrospinal
fluid cytopathology is positive.
2. Male or female aged between 18 and 75 years; Normal liver and kidney function;
WBC≥4000/mm3, Plt≥100000/mm3.
3. No history of severe nervous system disease; No severe dyscrasia.
Exclusion Criteria:
1. Any evidence of nervous system failure, including severe encephalopathy, grade 3 or
4 leukoencephalopathy on imaging, and Glasgow Coma Score less than 11.
2. Any evidence of extensive and lethal progressive systemic diseases without effective
treatment.
3. A history of HIV or AIDS, acute or chronic hepatitis B or C infection, previous
anti-PD1 therapy-induced pneumonitis, or have ongoing >Grade 2 adverse events of
such therapy; or ongoing autoimmune disease that required systemic treatment in the
past 2 years.
4. Patients with poor compliance or other reasons that were unsuitable for this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Guangzhou Medical University
Address:
City:
Huizhou
Country:
China
Contact:
Last name:
Zhenyu Pan
Phone:
+8618718178286
Email:
dr-zypan@163.com
Start date:
June 20, 2024
Completion date:
June 20, 2026
Lead sponsor:
Agency:
Guangzhou Medical University
Agency class:
Other
Source:
Guangzhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06462222
