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

Phase 2

Recruiting

• Conditions: Leptomeningeal Metastasis; Endostatin; Immune Checkpoint Inhibitor
• Interventions: Drug: Camrelizumab or envafolimab

• Registration Number: NCT05385185
• Lead Sponsor: Hebei Medical University

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.

Study Timeline

• Study First Submitted: 2021-07-07
• Status Verified: 2022-05
• Study Start: 2022-05-01
• Study First Submitted QC: 2022-05-19
• Last Update Submitted: 2022-05-19
• Study First Posted: 2022-05-23
• Last Update Posted: 2022-05-23
• Primary Completion: 2024-05-03
• Study Completion: 2024-12-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Leptomeningeal metastases received PD-1 inhibitor and recombinant human endostatin	Camrelizumab or envafolimab	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.

Primary Outcome Measures

Name	Time	Method
3-month overall survival rate	3 month	The 3-month survival rate after treatment
safty	2 years	Adverse events related to treatment

Secondary Outcome Measures

Name	Time	Method
iPFS	2 years	Intracranial progression-free survival
extracranial PFS	2 years	extracranial progression-free survival
DCR	2 years	disease control rate

Trial Locations

Locations (1)

The Second Hospital of Hebei Medical University; 🇨🇳 Hebei, China