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RecruitingPhase 1NCT06663306

Intrathecal Injection Pemetrexed And Bevacizumab in Patients With Leptomeningeal Metastases in NSCLC

Efficacy and Safety of Pemetrexed Combined With Bevacizumab Intrathecal Injection in Patients With Leptomeningeal Metastases in NSCLC

Sponsor

Shanghai Chest Hospital

Enrollment

19 participants

Start Date

Dec 9, 2024

Study Type

INTERVENTIONAL

Conditions

Leptomeningeal MetastasisLung Cancer (NSCLC)

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • 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;
  • 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 Criteria16

  • 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.

Interventions

DRUGPemetrexed

Intrathecal pemetrexed 50mg,twice per week (d1, d8) for 1 week, then once per 4 weeks

DRUGBevacizumab

Intrathecal bevacizumab, once (d8)for 1 week, then once per 4 weeks.The initial dose of intrathecal bevacizumab is 5 mg, escalated to 10 mg, and then 25 mg, and then 37.5mg, and then 50mg.

Locations(1)

Shanghai Chest Hospital

Shanghai, China

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NCT06663306

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