Intrathecal Injection Pemetrexed And Bevacizumab in Patients With Leptomeningeal Metastases in NSCLC
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Chest Hospital
About this trial
This is a prospective, single-arm, phase Ia clinical study, which was designed to evaluate the efficacy and safety of Pemetrexed Combined With Bevacizumab Intrathecal Injection in Patients With Leptomeningeal Metastases in NSCLC.
Eligibility criteria
Qualifiers
Age ≥ 18 years;
ECOG PS score 0-3. ECOG PS score 2 or 3 should be due to leptomeningeal metastases.
Patients with pathologically diagnosed non-small cell lung cancer with cerebrospinal fluid and/or MRI diagnosis of leptomeningeal metastasis(LM);
Unsatisfactory efficacy of LM,which defined as disease progression in LM,or LM-related neurological progression, while patients received standard systemic anti-tumor treatment;
Disqualifiers
Positive for human immunodeficiency virus (HIV) ;
History of allergy to pemetrexed or bevacizumab;
History of pemetrexed and/or bevacizumab intrathecal Injection;
Uncontrolled hypertension(systolic pressure≥150mmHg，or diastolic pressure≥100mmHg；History of hypertensive crisis or hypertensive encephalopathy;
Trial design
Treatments tested in this trial
- Pemetrexed
- Bevacizumab
Treatment groups
19 Participants
are divided into 2 treatment groupsSponsors and collaborators
Shanghai Chest Hospital
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Collaborator
Source ClinicalTrials.gov