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

NCT05385185 | Unknown Phase 2 DMC

• 1 other identifier: BH006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Leptomeningeal Metastasis; Immune Checkpoint Inhibitor; Endostatin

Outcome Measures

Primary Outcomes (2)

• 3-month overall survival rate

  The 3-month survival rate after treatment

  3 month

• safty

  Adverse events related to treatment

  2 years

Secondary Outcomes (3)

• iPFS

  2 years

• extracranial PFS

  2 years

• DCR

  2 years

Study Arms (1)

Leptomeningeal metastases received PD-1 inhibitor and recombinant human endostatin

EXPERIMENTAL

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

Camrelizumab or envafolimab DRUG

combine Camrelizumab or envafolimab with Recombinant human vascular endostatin

Also known as: Recombinant human vascular endostatin

Leptomeningeal metastases received PD-1 inhibitor and recombinant human endostatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Hebei Medical University: lead

Study Sites (1)

The Second Hospital of Hebei Medical University

Hebei, China

RECRUITING

MeSH Terms

Conditions

Meningeal Carcinomatosis

Interventions

camrelizumab; envafolimab

Condition Hierarchy (Ancestors)

Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Central Study Contacts

hui bu, PhD

CONTACT

0311-66003711-211; buhuimy1@163.com

jiao xue qi, master

CONTACT

1074234012@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The department of neurology

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: May 23, 2022
• Study Start: May 1, 2022
• Primary Completion: May 3, 2024
• Study Completion: December 3, 2024
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)