Clinical trial · Interventional
Efficacy and Safety of Recombinant Human Endostatin in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis
NCT04356118CI-TRIAL-00045258unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to observe the clinical effect and safety of Recombinant Human Endostatin in non-small cell lung cancer with leptomeningeal metastasis
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leptomeningeal Metastasis | Meningeal Carcinomatosis | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intrathcal methotrexate | Drug | — | UNRESOLVED |
| Recombinant Human Endostatin | Drug | — | UNRESOLVED |
| Targeted drugs for non-small cell lung cancer | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Endostatin Therapy for NSCLC of LM
- description
- Recombinant Human Endostatin + intrathcal methotrexate+Targeted drugs for non-small cell lung cancer Recombinant Human Endostatin:15mg/endostatin;The dose is 7.5mg/㎡/d，Once a day for two weeks, take a week off,start the next cycle, up to four cycles. intrathcal methotrexate :Intrathecal chemotherapy specified dose on specified days. Targeted drugs for non-small cell lung cancer: EGFR Mutation: Erlotinib，Afatinib，Osimertinib, et al. ALK ROS1 Mutation:Crizotinib,Ceritinib,Alectinib ,et al. BARF Mutation:Vemurafenib,et al. Other Mutation: other Targeted drugs .
- interventionNames
- Drug: Recombinant Human Endostatin
- Drug: intrathcal methotrexate
- Drug: Targeted drugs for non-small cell lung cancer
Primary outcomes (3)
- measure
- Leptomeningeal Metastasis Overall survival
- timeFrame
- 36 months
- description
- Leptomeningeal Metastasis Overall survival defined as time from LM diagnosis to death due to any cause or last follow-up
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age over 18 years old 2. Pathologically proven non-small cell lung cancer 3. Karnofsky performance status ≥ 40 4. LM diagnosis was based on the detection of malignant cells in the CSF, the focal or diffuse enhancement of leptomeninges, and nerve roots or the ependymal surface on gadolinium-enhanced MRI . 5. No severe abnormal liver and kidney function; 6. Patients have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Evidence of bleeding diathesis or serious infection 2. Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension) 3. Pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.