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Status unknownNCT05385185Updated May 23, 2022

Clinical Observation of ICI Combined With Recombinant Human Endostatin on Leptomeningeal Metastasis of Lung Cancer

A Phase 2 interventional study of Camrelizumab or envafolimab in Leptomeningeal Metastasis, Immune Checkpoint Inhibitor and Endostatin, sponsored by Hebei Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-23.

Sponsored by Hebei Medical University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

We will recruit 20 patients with leptomeningeal metastases from lung cancer.

02

Conditions studied

  • Leptomeningeal Metastasis
  • Immune Checkpoint Inhibitor
  • Endostatin
03

In context

Neoplasm Metastasis

3,514 studies on the registry are indexed under Neoplasm Metastasis; 883 are open to participants now.

This study's planned enrollment of 20 is below the median of 54 across 2,765 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Hebei Medical University is the lead sponsor of 39 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥18 years old, gender unlimited;
  2. A clear diagnosis of leptomeningeal metastases derived from lung cancer , including positive cerebrospinal fluid cytology and/or neuroimaging diagnosis;
  3. A clear history of lung cancer, including histopathological diagnosis, or a combination of cytopathology and imaging;
  4. Proper organ function (neutrophil count ≥1.5× 109 /L, platelet count ≥100× 109 /L, hemoglobin concentration ≥90g/L, serum transaminase concentration ≤2.5 times the limit of normal value, serum creatinine concentration ≤ 1.5 times the upper limit of normal value, proteinuria ≤1+)
  5. Dexamethasone ≤2 mg (or equivalent) 7 days before the start of treatment in patients requiring long-term use of the hormone
  6. Signed the informed consent and was willing to follow the experimental protocol and follow-up

Exclusion criteria

Exclusion Criteria:

  1. Patients with positive driver genes and effective treatment, such as patients with positive EGFR gene sensitive mutation
  2. Severe infections or serious comorbidities, such as hemorrhagic peptic ulcer, intestinal obstruction, heart failure, kidney failure, or poorly controlled diabetes;
  3. Be allergic to PD-1 inhibitor and recombinant human endostatin
  4. The female patient planned to be pregnant, was pregnant and lactating -
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Leptomeningeal metastases received PD-1 inhibitor and recombinant human endostatin

    Camrelizumab 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.

    Drug: Camrelizumab or envafolimab

Interventions

  • DrugCamrelizumab or envafolimab

    combine Camrelizumab or envafolimab with Recombinant human vascular endostatin

    Also known as: Recombinant human vascular endostatin

06

What researchers measure

Primary outcomes

  1. 3-month overall survival rate

    The 3-month survival rate after treatment

    Time frame: 3 month

  2. safty

    Adverse events related to treatment

    Time frame: 2 years

Secondary outcomes

  1. iPFS

    Intracranial progression-free survival

    Time frame: 2 years

  2. extracranial PFS

    extracranial progression-free survival

    Time frame: 2 years

  3. DCR

    disease control rate

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • The Second Hospital of Hebei Medical University
    Hebei, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — the patients information should be protected

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05385185
Lead sponsor
Hebei Medical University
Responsible party
Hui Bu (The department of neurology, Hebei Medical University) — Principal investigator
First posted
May 23, 2022
Start date
May 1, 2022
Primary completion
May 3, 2024 (estimated)
Completion
Dec 3, 2024 (estimated)
Last update
May 23, 2022

Study contacts

hui bu, PhD
Contact
buhuimy1@163.com
0311-66003711-211
jiao xue qi, master
Contact
1074234012@qq.com

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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