Last updated: May 19, 2022
Sponsor: Hebei Medical University
Overall Status: Active - Recruiting
Phase
2
Condition
Neoplasm Metastasis
Treatment
N/AClinical Study ID
NCT05385185
BH006
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥18 years old, gender unlimited;
- A clear diagnosis of leptomeningeal metastases derived from lung cancer , includingpositive cerebrospinal fluid cytology and/or neuroimaging diagnosis;
- A clear history of lung cancer, including histopathological diagnosis, or acombination 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 limitof normal value, serum creatinine concentration ≤ 1.5 times the upper limit of normalvalue, proteinuria ≤1+)
- Dexamethasone ≤2 mg (or equivalent) 7 days before the start of treatment in patientsrequiring long-term use of the hormone
- Signed the informed consent and was willing to follow the experimental protocol andfollow-up
Exclusion
Exclusion Criteria:
- Patients with positive driver genes and effective treatment, such as patients withpositive 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 -
Study Design
Total Participants: 20
Study Start date:
May 01, 2022
Estimated Completion Date:
December 03, 2024
Study Description
Connect with a study center
The Second Hospital of Hebei Medical University
Hebei,
ChinaActive - Recruiting
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