Last reviewed · How we verify
NCT04356118
Efficacy and Safety of Recombinant Human Endostatin in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis
Phase 4 trial testing Recombinant Human Endostatin in Leptomeningeal Metastasis in 30 participants. Status unknown.
1 June 2023
Quick facts
| Lead sponsor | Hui Bu |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 June 2020 |
| Primary completion | 1 June 2023 |
| Estimated completion | 1 June 2023 |
Drugs / interventions tested
- Recombinant Human Endostatin — full drug profile →
- intrathcal methotrexate — full drug profile →
- Targeted drugs for non-small cell lung cancer — full drug profile →
Conditions studied
- Leptomeningeal Metastasis — all drugs for Leptomeningeal Metastasis →
Sponsor
Hui Bu — full company profile →
Who can join
18 and older, any sex, with Leptomeningeal Metastasis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Leptomeningeal Metastasis Overall survival
Time frame: 36 months
Leptomeningeal Metastasis Overall survival defined as time from LM diagnosis to death due to any cause or last follow-up -
Neurological Progression Free Survival
Time frame: 36 months
From the start of treatment until central nervous system metastase progression or death due to any cause -
The incidence of adverse reactions
Time frame: 36 months
From date of first dose up to assessed from April 2020 to April 2023 (In accordance with the standard of CTCAE)
Sponsor's own description
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
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Leptomeningeal Metastases from Solid Tumors: Recent Advances in Diagnosis and Molecular Approaches.
Pellerino A, Brastianos PK, Rudà R, Soffietti R. · · 2021 · cited 32× · PMID 34207653 · DOI 10.3390/cancers13122888 -
Leptomeningeal Metastases: New Opportunities in the Modern Era.
Wilcox JA, Li MJ, Boire AA. · · 2022 · cited 25× · PMID 35790709 · DOI 10.1007/s13311-022-01261-4 -
Sustained Improvement in the Management of Patients with Non-Small-Cell Lung Cancer (NSCLC) Harboring ALK Translocation: Where Are We Running?
Spitaleri G, Trillo Aliaga P, Attili I, Del Signore E, et al · · 2023 · cited 8× · PMID 37232842 · DOI 10.3390/curroncol30050384
Verify or expand the search:
- PubMed search for NCT04356118
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Recombinant Human Endostatin
Trials testing the same drug.
- NCT03925233 — Breast Cancer Treatment Based on Organ-like Culture · unknown
Other recruiting trials for Leptomeningeal Metastasis
Currently open trials in the same condition.
- NCT07348965 — Pulsatile High-dose Furmonertinib in EGFR-mutant NSCLC With Leptomeningeal Metastasis · NA · recruiting
- NCT07398599 — Double-Dose Third-Generation EGFR-TKI Plus Bevacizumab and Intrathecal Chemotherapy for Refractory Leptomeningeal Metast · NA · recruiting
- NCT06296745 — Intrathecal Pemetrexed for Leptomeningeal Metastasis From Lung Adenocarcinoma That Progressed After Osimertinib. · Phase 2 · recruiting
- NCT07098806 — Multiple Dose Intraventricular Administration of Rhenium-186 NanoLiposome for Leptomeningeal Metastases · Phase 1 · recruiting
- NCT06984523 — Study of Craniospinal Irradiation With Linac Based Volumetric Modulated Arc Therapy (VMAT) for Patients With Leptomening · NA · active not recruiting
Other Hui Bu trials
Trials by the same sponsor.
- NCT04833205 — Clinical Efficacy and Safety of EGFR-TKI Combined With Nimotuzumab in the Treatment of Leptomeningeal Metastases From Lu · Phase 2 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04356118 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hui Bu
- Last refreshed: 23 May 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04356118.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing