Clinical trial · Interventional
Clinical Observation of ICI Combined With Recombinant Human Endostatin on Leptomeningeal Metastasis of Lung Cancer
NCT05385185CI-TRIAL-00058659unknownPhase 2ClinicalTrials.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)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endostatin | — | UNRESOLVED | — |
| Immune Checkpoint Inhibitor | — | UNRESOLVED | — |
| Leptomeningeal Metastasis | Meningeal Carcinomatosis | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Camrelizumab or envafolimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Leptomeningeal metastases received PD-1 inhibitor and recombinant human endostatin
- description
- 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.
- interventionNames
- Drug: Camrelizumab or envafolimab
Primary outcomes (2)
- measure
- 3-month overall survival rate
- timeFrame
- 3 month
- description
- The 3-month survival rate after treatment
- measure
- safty
- timeFrame
- 2 years
- description
- Adverse events related to treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 -
References
Publications (0)
Data not yet available
No reference posted for this study.