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

Leptomeningeal Metastasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05385185
• Other study ID #: BH006
• Status: Recruiting
• Phase: Phase 2
• Start date: May 1, 2022
• Est. completion date: December 3, 2024

Study information

• Verified date: May 2022
• Source: Hebei Medical University
• Contact: hui bu, PhD
• Phone: 0311-66003711-211
• Email: buhuimy1[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 3, 2024
• Est. primary completion date: May 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Endostatin
• Immune Checkpoint Inhibitor
• Leptomeningeal Metastasis
• Meningeal Carcinomatosis
• Neoplasm Metastasis

Intervention

Drug:
• Camrelizumab or envafolimab
combine Camrelizumab or envafolimab with Recombinant human vascular endostatin

Locations

Country	Name	City	State
China	The Second Hospital of Hebei Medical University	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-month overall survival rate	The 3-month survival rate after treatment	3 month
Primary	safty	Adverse events related to treatment	2 years
Secondary	iPFS	Intracranial progression-free survival	2 years
Secondary	extracranial PFS	extracranial progression-free survival	2 years
Secondary	DCR	disease control rate	2 years