Status:
UNKNOWN
Clinical Observation of ICI Combined With Recombinant Human Endostatin on Leptomeningeal Metastasis of Lung Cancer
Lead Sponsor:
Hebei Medical University
Conditions:
Leptomeningeal Metastasis
Immune Checkpoint Inhibitor
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- Age ≥18 years old, gender unlimited;
- A clear diagnosis of leptomeningeal metastases derived from lung cancer , including positive cerebrospinal fluid cytology and/or neuroimaging diagnosis;
- A clear history of lung cancer, including histopathological diagnosis, or a combination of cytopathology and imaging;
- 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+)
- Dexamethasone ≤2 mg (or equivalent) 7 days before the start of treatment in patients requiring long-term use of the hormone
- Signed the informed consent and was willing to follow the experimental protocol and follow-up
Exclusion
- Patients with positive driver genes and effective treatment, such as patients with positive EGFR gene sensitive mutation
- Severe infections or serious comorbidities, such as hemorrhagic peptic ulcer, intestinal obstruction, heart failure, kidney failure, or poorly controlled diabetes;
- Be allergic to PD-1 inhibitor and recombinant human endostatin
- The female patient planned to be pregnant, was pregnant and lactating -
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 3 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05385185
Start Date
May 1 2022
End Date
December 3 2024
Last Update
May 23 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Second Hospital of Hebei Medical University
Hebei, China