NCT06663306RecruitingPhase 1
Efficacy and Safety of Pemetrexed Combined With Bevacizumab Intrathecal Injection in Patients With Leptomeningeal Metastases in NSCLC
Shanghai Chest Hospital1 site in 1 country19 target enrollmentStarted: November 30, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Shanghai Chest Hospital
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Incidence of Adverse Events (Safety and Tolerability)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years;
- •ECOG PS score 0-
- •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;
- •Expected survival time ≥ 1 month;
- •The laboratory test results meet the following criteria:Hemoglobin ≥ 90 g/L, neutrophil count ≥ 1.5 × 10^9/L, platelet count ≥ 100 × 10^9/L; Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN ; Creatinine≤ 2.0 × ULN,or Creatinine clearance rate (CrCl) ≥ 50 mL/min;
- •Females of child-bearing potential agree to use contraception during the study period and for 6 months after the completion of the study; patients who have had a negative serum or urine pregnancy test within seven days prior to enrollment in the study and who are not breastfeeding; and males agreeing to use contraception during the study period and for 6 months after the completion of the study;
- •Understand and sign the informed consent form.
Exclusion Criteria
- •Positive for human immunodeficiency virus (HIV) ;
- •History of allergy to pemetrexed or bevacizumab;
- •History of pemetrexed and/or bevacizumab intrathecal Injection;
- •Presence of contraindication of bevacizumab:
- •Uncontrolled hypertension(systolic pressure≥150mmHg，or diastolic pressure≥100mmHg；History of hypertensive crisis or hypertensive encephalopathy;
- •Urine protein≥2+,or 24-hour urine protein≥2g；
- •Unstable angina pectoris, symptomatic congestive heart failure,myocardial infarction within 6 months before enrollment, severe vascular disease, severe uncontrolled arrhythmia;
- •Major hemoptysis within the past 1 month; History of coagulation disorders;
- •Presence of serious non-healing wounds, ulcers, or bone fractures
- •Presence of abdominal fistula, gastrointestinal perforation, or gastrointestinal tract obstruction;
- •Presence of macrovascular invasion；
- •Some neurological disorders unrelated to tumors，such as intracranial infection,cerebral hemorrhage,cerebral infarction,encephalitis;
- •Brain/spinal cord radiation therapy within 1 week before enrollment;
- •Pregnant and lactating female;
- •Refuse to use contraception during the study period;
- •Individuals considered by the investigator to be unsuitable for enrollment.
Arms & Interventions
Arm A
Experimental
Enrolled patients were treated with pemetrexed intrathecal injection
Intervention: Pemetrexed (Drug)
Arm B
Experimental
Enrolled patients were treated with pemetrexed combined with bevacizumab intrathecal injection
Intervention: Pemetrexed (Drug)
Arm B
Experimental
Enrolled patients were treated with pemetrexed combined with bevacizumab intrathecal injection
Intervention: Bevacizumab (Drug)
Outcomes
Primary Outcomes
Incidence of Adverse Events (Safety and Tolerability)
Time Frame: From the beginning of the treatment until two months after the treatment.
Number of participants with adverse events, treatment emergent adverse events,and serious adverse events assessed by CTCAE v5.0 as a measure of safety and tolerability.
Secondary Outcomes
- Overall Survival (OS)(Up to 2 years)
Investigators
Hua Zhong
Chief of Respiratory Department
Shanghai Chest Hospital
Study Sites (1)
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