Clinical Observation of ICI Combined With Recombinant Human Endostatin on Leptomeningeal Metastasis of Lung Cancer
- Sponsor
- Hebei Medical University
- Study ID
- NCT05385185
- Phase
- PHASE2
- Status
- Unknown
Conditions
- Endostatin
- Immune Checkpoint Inhibitor
- Leptomeningeal Metastasis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Camrelizumab or envafolimab — DRUGcombine Camrelizumab or envafolimab with Recombinant human vascular endostatin
Study Details
immune checkpoint inhibitor combined with recombinant human endostatin can improve the 3-month OS rate of leptomeningeal metastasis of lung cancer, and the combination is safe
Key Dates
- Start date
- May 1, 2022
- Status verified
- May 2022
- Primary completion
- May 3, 2024
- Completion
- Dec 3, 2024
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Leptomeningeal metastases received PD-1 inhibitor and recombinant human endostatinCamrelizumab 200mg intravenously, once every 21 days or envafolimab 150mg subcutaneous injection,once a week Endostatin 30mg/d was administered intravenously for 7 days (d1-d7). The interval between Endostatin and next was 2 weeks.
Primary Outcome Measure
3-month overall survival rate [ Time Frame: 3 month ]
Central Contacts
- hui bu, PhD0311-66003711-211
- jiao xue qi, master
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