Clinical Observation of ICI Combined With Recombinant Human Endostatin on Leptomeningeal Metastasis of Lung Cancer

Last updated: May 19, 2022
Sponsor: Hebei Medical University
Overall Status: Active - Recruiting

Phase

2

Condition

Neoplasm Metastasis

Treatment

N/A

Clinical Study ID

NCT05385185
BH006
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years old, gender unlimited;
  2. A clear diagnosis of leptomeningeal metastases derived from lung cancer , includingpositive cerebrospinal fluid cytology and/or neuroimaging diagnosis;
  3. A clear history of lung cancer, including histopathological diagnosis, or acombination 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 limitof normal value, serum creatinine concentration ≤ 1.5 times the upper limit of normalvalue, proteinuria ≤1+)
  5. Dexamethasone ≤2 mg (or equivalent) 7 days before the start of treatment in patientsrequiring long-term use of the hormone
  6. Signed the informed consent and was willing to follow the experimental protocol andfollow-up

Exclusion

Exclusion Criteria:

  1. Patients with positive driver genes and effective treatment, such as patients withpositive 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 -

Study Design

Total Participants: 20
Study Start date:
May 01, 2022
Estimated Completion Date:
December 03, 2024

Study Description

We will recruit 20 patients with leptomeningeal metastases from lung cancer.

Connect with a study center

  • The Second Hospital of Hebei Medical University

    Hebei,
    China

    Active - Recruiting

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