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

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

Study Overview

• Status: Recruiting
• Conditions: Leptomeningeal Metastasis; Immune Checkpoint Inhibitor; Endostatin
• Intervention / Treatment: Drug: Camrelizumab or envafolimab

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hebei, China
    • Recruiting
    • The Second Hospital of Hebei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; combine Camrelizumab or envafolimab with Recombinant human vascular endostatin; Other Names: Recombinant human vascular endostatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-month overall survival rate	The 3-month survival rate after treatment	3 month
safty	Adverse events related to treatment	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
iPFS	Intracranial progression-free survival	2 years
extracranial PFS	extracranial progression-free survival	2 years
DCR	disease control rate	2 years

Collaborators and Investigators

• Sponsor: Hebei Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2022
• Primary Completion (ANTICIPATED): May 3, 2024
• Study Completion (ANTICIPATED): December 3, 2024

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (ACTUAL): May 23, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Meningeal Neoplasms; Neoplasm Metastasis; Meningeal Carcinomatosis; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Endostatins
• Other Study ID Numbers: BH006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: the patients information should be protected

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No