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

Primary Purpose

Leptomeningeal Metastasis, Immune Checkpoint Inhibitor, Endostatin

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Camrelizumab or envafolimab
Sponsored by
Hebei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leptomeningeal Metastasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  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 -

Sites / Locations

  • The Second Hospital of Hebei Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Leptomeningeal metastases received PD-1 inhibitor and recombinant human endostatin

Arm Description

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.

Outcomes

Primary Outcome Measures

3-month overall survival rate
The 3-month survival rate after treatment
safty
Adverse events related to treatment

Secondary Outcome Measures

iPFS
Intracranial progression-free survival
extracranial PFS
extracranial progression-free survival
DCR
disease control rate

Full Information

First Posted
July 7, 2021
Last Updated
May 19, 2022
Sponsor
Hebei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05385185
Brief Title
Clinical Observation of ICI Combined With Recombinant Human Endostatin on Leptomeningeal Metastasis of Lung Cancer
Official Title
Clinical Observation of ICI Combined With Recombinant Human Endostatin on Leptomeningeal Metastasis of Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
May 3, 2024 (Anticipated)
Study Completion Date
December 3, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leptomeningeal Metastasis, Immune Checkpoint Inhibitor, Endostatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Leptomeningeal metastases received PD-1 inhibitor and recombinant human endostatin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Camrelizumab or envafolimab
Other Intervention Name(s)
Recombinant human vascular endostatin
Intervention Description
combine Camrelizumab or envafolimab with Recombinant human vascular endostatin
Primary Outcome Measure Information:
Title
3-month overall survival rate
Description
The 3-month survival rate after treatment
Time Frame
3 month
Title
safty
Description
Adverse events related to treatment
Time Frame
2 years
Secondary Outcome Measure Information:
Title
iPFS
Description
Intracranial progression-free survival
Time Frame
2 years
Title
extracranial PFS
Description
extracranial progression-free survival
Time Frame
2 years
Title
DCR
Description
disease control rate
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years old, gender unlimited; A clear diagnosis of leptomeningeal metastases derived from lung cancer , including positive cerebrospinal fluid cytology and/or neuroimaging diagnosis; A clear history of lung cancer, including histopathological diagnosis, or a combination of cytopathology and imaging; 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+) Dexamethasone ≤2 mg (or equivalent) 7 days before the start of treatment in patients requiring long-term use of the hormone Signed the informed consent and was willing to follow the experimental protocol and follow-up Exclusion Criteria: Patients with positive driver genes and effective treatment, such as patients with positive EGFR gene sensitive mutation Severe infections or serious comorbidities, such as hemorrhagic peptic ulcer, intestinal obstruction, heart failure, kidney failure, or poorly controlled diabetes; Be allergic to PD-1 inhibitor and recombinant human endostatin The female patient planned to be pregnant, was pregnant and lactating -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hui bu, PhD
Phone
0311-66003711-211
Email
buhuimy1@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
jiao xue qi, master
Email
1074234012@qq.com
Facility Information:
Facility Name
The Second Hospital of Hebei Medical University
City
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hui bu, phD
Phone
13831106903
Email
buhuimy1@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
the patients information should be protected

Learn more about this trial

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

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